Author: Randy Chase

The FDA approved the 35th biosimilar last week, Alymsys (bevacizumab-maly) from Amneal Pharmaceuticals, for seven cancer indications of the reference product, Avastin from Genentech. It is an infused therapy, so specialty pharmacies won’t have much contact with Alymsys.

Alymsys joins two previously approved biosimilars to Avastin. Myvasi (Amgen, approved in 2017) and Zirabev (Pfizer, approved in 2019).

Patent concerns?
Patent battles were in full bore for years but Avastin did not have the dozens of patents to block competitor approvals as seen in other biosim cases. With the final patent issues resolved, doors are now open for the three biosimilars. Inroads into market share were slow on the uptake but are gaining share rapidly as competition will further gain payer preferences.

Follow the Money
Is all the wait worth it? In short, yes….. especially for Amneal which did not have to spend a mountain of cash on legal challenges. These biosimilars are being sold outside the US and are generating revenues for the biosim manufacturers.

Avastin isn’t the most expensive therapy in the cancer toolbox, but it isn’t cheap either at about $4,000 per cycle. Depending on cancer type and other clinical variables, a patient may receive as few as six cycles or as many as 22. By the way….. Avastin is still among the top selling drugs on the market. Nuff said….

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FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly

April 13, 2022 — Amneal said the product, to be sold under the name Alymsys.
It is the second of 3 biosimilars the company expects earn approval in the US this year.

Amneal Pharmaceuticals Wednesday said the FDA approved the company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing the originator product (Avastin).

Amneal said the product will be sold under the name Alymsys. It is the third bevacizumab biosimilar approved in the United States.

Earlier this year, Amneal received approval of filgrastim-ayow (Releuko) which references Neupogen. The firm’s pegfilgrastim biosimilar referencing Neulasta is currently under FDA review.

Bevacizumab-maly was developed by mAbxience. The vascular endothelial growth factor inhibitor is indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen
First-line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel
Recurrent glioblastoma in adults
Metastatic renal cell carcinoma in combination with interferon alfa
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel

Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.

The National Home Infusion Association (NHIA) recently published the results of a survey of patients who had received a home chemotherapy infusion to gauge their level of satisfaction across a number of metrics. The results show that these home infusion patients are very satisfied with services, understand medication instructions, and 89.54% of the patients completed their therapy with only 0.02% adverse reactions related to the administration.

National Home Infusion Association (NHIA) estimates that approximately 132,000+ patients annually received home infusions of chemotherapy agents since 2019 with the trend increasing. Given the criticism of home chemo infusions by hospital-based infusion providers it is not surprising that NHIA would want to ensure that their patients were satisfied with the home infusion experience.

The purpose of this study was to quantify the level of patient satisfaction and to determine any reason for discontinuation from home infusion services. The findings showed a very low rate of discontinuation with more than 90% completing therapy. Of those that did not complete therapy 8+-% died of non-administration-related causes or were hospitalized for non-administration-related causes.

As noted in the published table (click below), patient ratings were very strong in support of home provided services with the majority of metrics in the 90%++ range (strongly agree).

Some deeper evaluation is required related to two outlier results. Question 11, “I was satisfied with the overall quality of the home infusion services provided” dropped precipitously. NHIA points out that when the top two results are combined (Strongly Agree and Mostly Agree) the results increase to 97%. The score in Question 12 – “I would recommend home infusion to family and friends,” similarly suffered but fares much better when the top two options are combined. Future surveys may want to take a deeper dive in these areas to understand patient thinking or rephrasing certain questions.

Several questions relate specifically to the local home infusion company. However, others can be attributable to the specialty pharmacy providing both the therapy and critical services, e.g., authorization and billing (usually worked out before shipment of the drug to the home care company.) For example, in Question 3 patients are asked about delivery of the medication prior to the scheduled appointment. It received the third lowest score and indicates an opportunity for a specialty pharmacy quality improvement assessment.

CLICK HERE to read the full text of the report and VIEW THE TABLE

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Chemo at Home: High Rate of Satisfaction, Low Rate of Discontinuation

Overall, 97% of patients said they were satisfied with at-home chemotherapy infusions.

The following article features coverage from the NCCN 2022 Annual Conference.

Receiving chemotherapy infusions at home appears to be safe, and patients reported a high rate of satisfaction, according to research presented at the NCCN 2022 Annual Conference.

Most patients in the study completed at-home chemotherapy as planned, and none of them stopped treatment because of adverse drug reactions.

In a survey, most patients said they understood their medication instructions, were informed about potential side effects, and were satisfied with at-home chemotherapy.

Researchers assessed the safety of home chemotherapy infusions in 153 patients using 3 parameters — treatment completion, adverse drug reactions, and unplanned hospitalizations.

The researchers also surveyed 328 at-home chemotherapy recipients using a 12-question survey developed by the National Home Infusion Association. The survey responses were submitted between 2019 and 2021.

The survey used a Likert scale (“strongly agree” to “strongly disagree”), and the following answers are the highest rated option (“strongly agree”).

All patients said the home infusion pump was clean when delivered, and 99% said it worked properly. Most patients said they knew who to call for help (98%), responses to after-hours calls met their needs (86%), and the nurse or pharmacist explained the possible side effects of treatment (91%).

Nearly all patients said they understood the instructions on how to wash their hands (98%), give home infusion medications (97%), care for the IV catheter (97%), store their medications (96%), and use the home infusion pump (98%).

Jen Smith for Journal of National Comprehensive Cancer Network

Simpson MC, Haines DJ. Patient satisfaction and reason for discontinuation of home infusion for cancer patients. Presented at NCCN 2022 Annual Conference; March 31 – April 2, 2022. Abstract HSR22-168.

Last week the FDA approved a new ORAL specialty therapy, Vijoice (alpelisib) from Novartis Pharmaceuticals, indicated for breast cancer patients with evidence of mutation in the PIK3CA gene. Vijoice is a PI3K inhibitor that treats PIK3CA-related overgrowth spectrum (PROS) (a term for the rare condition that causes blood vessel abnormalities and overgrowth of tissue.)

Prior to this approval, the only treatment options for PROS were surgery or interventional radiology. Sold as the blockbuster drug Piqray (approved for breast cancer in 2019), alpelisib will be marketed under the brand name Vijoice for severe manifestations of PROS in adults and children two years of age or older. Available dosages of Vijoice differ from that of Piqray. Vijoice is the only drug specifically approved for the condition.

The recommended alpelisib dosage for pediatric patients (2-18 years of age) is 50 mg taken orally. The recommended dosage for adult patients (≥ 18 years) is 250 mg taken orally.

Novartis priced Vijoice at a wholesale cost of $32,500 for a 28-day course of therapy.The cost for Piqray oral tablets is around $19,555 for a 28-day course.

Given the rarity and cost of PROS it is expected that Vijoice will launch into limited distribution.

CLICK HERE to access Vijoice prescribing information

CLICK HERE to access Piqray prescribing information

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FDA approves alpelisib for PIK3CA-related overgrowth spectrum

On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.

Efficacy was evaluated using real-world data from EPIK-P1 (NCT04285723), a single-arm clinical study in patients two years of age and older with PROS who received alpelisib as part of an expanded access program for compassionate use. Eligible patients had clinical manifestations of PROS that were assessed by the treating physicians as severe or life-threatening and necessitating systemic treatment and had documented evidence of mutation in the PIK3CA gene. The efficacy of alpelisib was evaluated in a total of 37 patients with at least one target lesion identified on imaging performed within 24 weeks prior to receipt of the first dose.

The major efficacy outcome measure was the proportion of patients with radiological response at week 24 as determined by blinded independent central radiology review, defined as a ≥20% reduction from baseline in the sum of measurable target lesion volume in up to 3 lesions confirmed by at least 1 subsequent imaging assessment. Duration of response was an additional efficacy outcome measure. Of the 37 patients included in the efficacy population, 27% (95% CI: 14, 44) had a radiological response at Week 24. Among responding patients, 60% had a response lasting 12 months or longer. 

The most common (≥ 10%) adverse reactions occurring in patients were diarrhea, stomatitis, and hyperglycemia.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review, breakthrough designation and orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

The FDA recently approved Opdualag (nivolumab and relatlimab-rmbw) from Bristol Myers Squibb, a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab1. The indication for this combo therapy is for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

This approval advances the trend toward combo therapies. For example, Opdivo, first approved in December of 2014, paired with Yervoy (another BMS therapy) in late 2020 for Mesothilioma and now the newly approved BMS therapy, relatlimab-rmbw for Melanoma.

Opdualag is an infused therapy administered every four weeks. Since the combo includes both an established therapy and a newly approved therapy the FDA determined that a distinct name and NDC be established. BMS indicated that relatlimab will only be sold in combination with Opdivo.

BMS said that Opdualag will launch at $27,389 for the combination with forecasted sales of $4 billion a year by 2029. Details on channel access / limited distribution were not provided.

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U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma

Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy, an established standard of care

Relatlimab is the third immune checkpoint inhibitor from Bristol Myers Squibb, adding to the Company’s growing and differentiated oncology portfolio

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdualag (nivolumab and relatlimab-rmbw), a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2

The trial met its primary endpoint, progression-free survival (PFS), and Opdualag more than doubled the median PFS when compared to nivolumab monotherapy, 10.1 months (95% Confidence Interval [CI]: 6.4 to 15.7) versus 4.6 months (95% CI: 3.4 to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 to 0.92, P=0.0055).1 The Opdualag safety profile was similar to that previously reported for nivolumab.1,2 No new safety events were identified with the combination when compared to nivolumab monotherapy.1,2 Grade 3/4 drug-related adverse events were 18.9% in the Opdualag arm compared to 9.7% in the nivolumab arm.2 Drug-related adverse events leading to discontinuation were 14.6% in the Opdualag arm compared to 6.7% in the nivolumab arm.2

“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” said F. Stephen Hodi, M.D., director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute.3 “Today’s approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1.”1,2

Opdualag is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions (IMARs) including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, myocarditis and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); and embryo-fetal toxicity.1 Please see Important Safety Information below.

“While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients,” said Samit Hirawat, chief medical officer, global drug development, Bristol Myers Squibb.3 “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients. The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”

HIPAA…. the lurking threat to every specialty pharmacy.

That’s a provocative statement….. but one that rings all too true.

Each year we hear of yet another SP that gets targeted for a HIPAA violation that, more often than not, has resulted in costly fines.

The news report below details yet another lawsuit for a HIPAA violation by a leading specialty pharmacy. Best efforts to prevent all data breaches are nearly impossible to guarantee….. but they can be useful in mitigating the scope of the breach and even the fines that are assessed.

Here are some factoids that are worth remembering…..

·     The largest HIPAA fine paid in the past five years was $16 million by Anthem due to insufficient ePHI Access Controls.

·     The smallest fine last year, $65,000, was paid this past December by an ambulance company.

·     A $100,000 fine was assessed on a company that had closed a year prior.

·     The largest fine paid by a pharmacy, $125,000, was for failure to properly dispose of paper records containing PHI.

·     Between 2009 and 2018 there have been 2,546 healthcare data breaches (involving more than 500 records). Those breaches have resulted in the theft/exposure of 189,945,874 healthcare records. That equates to more than 59% of the population of the United States.

·     Fines and consequences can range from $100 to $50,000 per violation (or per record), with a maximum penalty of $1.5 million per year for each violation.

·     The Office for Civil Rights, a division of the Department of Health and Human Service (HHS), is responsible for HIPAA oversight.

Top 10 Most Common HIPAA Violations

1. Keeping Unsecured Records

2. Unencrypted Data

3. Hacking

4. Loss or Theft of Devices

5. Lack of Employee Training

6. Gossiping / Sharing PHI

7. Employee Dishonesty

8. Improper Disposal of Records

9. Unauthorized Release of Information

10. 3rd Party Disclosure of PHI (e.g., Business Associate)

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Florida Pharmacy Services Sued Over HIPAA Violations

The Middle District of Florida has filed a case against BioPlus Specialty Pharmacy Services. The case is related to disclosure of data protected by the Health Insurance Portability and Accountability Act (HIPAA).

The plaintiff was a customer of the defendants; the complaint explained that as a result she provided Personally Identifiable Information (PII) and Personal Health Information (PHI) to the defendant pharmacy. This information included her name, address, and other information.

The complaint said that the defendant was obligated under HIPAA to protect this information which it utilized to process and fulfill pharmacy needs. However, the defendant reported that its network was subject to a data breach and the information was retrieved by an outside party.

The plaintiff accuses the defendant of maintaining insufficient network security and failing to timely notify the potential class of victims of the data breach.

The plaintiff is seeking class certification and suing for negligence and declaratory judgment. They are represented by Morgan & Morgan and Markovits, Stock, & DeMarco LLC.

The FDA recently approved a new oral suspension therapy, Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. Ztalmy was developed by Marinus Pharmaceuticals and is supplied as an oral suspension.

Patients with CDKL5 deficiency disorder (CDD) typically have infantile-onset epilepsy that responds poorly to previously available treatments. Symptoms include hypotonia (poor muscle tone), severe developmental and cognitive delays with little or no speech production, fine and gross motor impairment (including inability to walk for most patients), cortical visual impairment, behavioral abnormalities, and sleep and digestive difficulties. 

CDD is a rare disease with an incidence of between 1 in 40,000-60,000 live births, making it one of the most common genetic forms of epilepsy. This translates into ~6,500 lives in the US.
Marinus announced that Ztalmy will launch in Q3 pending DEA controlled substance approval. It will have a WAC of $133,000 per patient per year and will average $105,000 per patient per year after discounts.

Given the small patient opportunity and clinical complexity of the therapy it is very likely that access to Ztalmy will be limited to a specialty pharmacy.

CLICK HERE to access prescribing information

https://marinuspharma.com/wp-content/uploads/2022/03/prescribing-information.pdf

The FDA recently approved a new infused therapy, Carvykti (iltacabtagene autoleucel), from Janssen Biotech, for the treatment of adult patients with relapsed or refractory multiple myeloma.   The therapy was developed in partnership with Legend Biotech. The partners will share marketing in the US.

Carvykti is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using a patient’s own T-cells, which are collected and genetically modified, and infused back into the patient.

Carvykti will compete in the market with another BCMA-targeted CAR-T drug approved a year ago, Abecma from 2seventy bio. Janssen announced that Carvykti will launch at a wholesale acquisition cost of $465,000 vs. Abecma’s $419,500 list price.

Carvykti was approved with an extensive BOXED WARNING as well as a restrictive access REMS program.

Janssen did not announce details on distribution or whether access would be through a specialty pharmacy distribution program.

CLICK HERE to read the full FDA press release

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are two LD deals that have been recently publicly confirmed subsequent to the approvals.

Soleo Health Selected as Limited Distribution Partner for VYVGART
January 24, 2022 — FRISCO, TX– Soleo Healthannounced today it was selected as a limited distribution partner for VYVGART™ (efgartigimod alfa-fcab) by argenx SE. VYVGART was approved by the U.S. Food & Drug Administration (FDA) on December 17, 2021 for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Soleo Health will manage and administer VYVGART intravenously in patients’ homes or its ambulatory infusion centers nationwide. Patients are supported through Soleo Health’s Myasthenia Gravis Therapeutic Care Management Center (TCMC). The TCMC is staffed with specially trained interdisciplinary teams, comprising experienced therapy care pharmacists, registered nurses, reimbursement specialists and patient care ambassadors dedicated to supporting patients living with myasthenia gravis.

PANTHERx Rare Selected as Exclusive Distribution Partner for FYARRO
Feb. 24, 2022 – PITTSBURGH, PA– PANTHERx Rare announces that it has been selected by Aadi Bioscience as the exclusive U.S. pharmacy distribution partner for new drug FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound). FYARRO, an albumin-bound mTOR inhibitor administered as an injectable suspension, is the first FDA-approved therapy for the treatment of advanced malignant perivascular epithelioid cell neoplasm (PEComa), an ultra-rare sarcoma.

Advanced PEComa is a rare, aggressive subset of soft tissue sarcomas for which there are no other approved therapeutic options. PEComas are composed of histologically and immunohistochemically distinctive epithelioid cells and most commonly arise from visceral, retroperitoneal, and abdominopelvic sites.

Over the past decade more and more specialty pharmacies obtained wholesaler/distributor (WDD / 3pl) licenses in addition to the traditional pharmacy license. Most of the therapies sold under those licenses are direct-to-provider for in office/clinic administration and commonly buy-and-bill. As you probably know, a majority of these meds are very high cost and are related to a limited / exclusive distribution program with the manufacturer.

The FDA is now moving to impose new rules that will supersede state regulations for these transactions, such as requiring national licensing, and ramped up operational standards and more. Legal experts on this matter believe that the proposed rule could have a significant impact on WDD and 3PL business operations. 

This is the time that SPs distributing meds under a state wholesale/distributor licenses to immediately assess all impacts to their business model and submit comments to FDA on the proposed rule changes by June 6, 2022 (Docket No. FDA-2020-N-1663).  You snooze you lose!

The FDA intends to conduct a webinar to provide an overview of the proposed rule to help stakeholders understand the proposed rules and prepare comments. 

The key provisions of the proposed rule include the following:

• Definitions of additional terms to help clarify the requirements of the proposed rule and align with current industry practice and existing law, including “3PL activities”, “key personnel”, “minimal quantities”, “other logistics services”, “other than a consumer or patient”, “product”, and “wholesale distribution”;
• National licensure and application requirements for WDDs and 3PLs, as well as the federal licensure review process;
• Standards and procedures that set forth licensure denial, suspension, reinstatement, revocation, and voluntary termination, including notice and the opportunity to request a formal evidentiary public hearing under existing FDA hearing procedures;
• Requirements for pre-license and post-license inspections;
• Personnel requirements and qualifications necessary for licensure;
• Surety bond requirements for WDDs;
• Requirements to establish good storage practices, including personnel requirements and qualifications necessary for good storage practices compliance;
• Requirements and standards for written policies and procedures to address a product’s sale, purchase, receipt, examination, security, storage, handling, inventory, shipment, transportation, disposition, and distribution;
• Requirements, standards, and procedures for record keeping, document maintenance, and initial and annual reporting; and
• Requirements, standards, and procedures for the FDA’s approval of third-party accreditation or inspection services or programs (“approved organizations” or “AOs”) to review the qualifications of 3PLs for licensure and conduct inspections of 3PL and WDD facilities, including the standards and procedures for organizations whose requests for approval are denied and for AOs whose approvals are suspended or revoked.

CLICK HERE to access the full Proposed FDA Rule

CLICK HERE to read the FDA Press Release including links to related documents 
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FDA Publishes Proposed Rule on National Standards for The Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers as Required by The Drug Supply Chain Security Act

March 11, 2022 — The US Food and Drug Administration (FDA) published its proposed rule National Standards for the licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) with the goal of strengthening the security of the US drug supply chain. When finalized and effective, these licensing regulations will preempt state and local licensing standards, requirements, and regulations that are different from these federal requirements.
CLICK HERE to read the full article from the National Law Review

Specialty pharmacies have seen margins shrink in spite of increasing volume. Many SPs turned to automation and clinically intuitive customer service software enabled SPs to improve speed to therapy and maintain quality of care standards. But overhead continues to be very people heavy. In short, bodies in the pharmacy and on the phone with customers are a big $$$ element of the delivery model.

It is not surprising, therefore, that SPs would look to their infantry in the pharmacy, pharmacy technicians, to shoulder a larger role in the delivery model. With tight clinical pharmacist availability and salaries rising, a certified pharmacy tech could be counted on to fill the gap. So, it should be no surprise that SPs interested in promoting their clinical quality would also want their techs to polish their clinical and operational expertise.

As noted in the article below, the CPhT has announced new course ware to enable pharmacy techs to obtain certifications in a variety of professional areas.

The certifications include the following:
– Advanced Certified Pharmacy Technician (CPhT-Adv),
– Board Certified Sterile Compounding Pharmacy Technician (BCSCPT),
– Board Certified Nonsterile Compounding Pharmacy Technician (BCNSPT).
Specialty certificates include:
– Technician Product Verifications (TPV)
– Medication History
– Controlled Substance Diversion Prevention
– Hazardous Drug Management
– Billing & Reimbursement
– Immunization Administration
– Point-of-Care Testing,
– Medication Therapy Management (MTM)
– Regulatory Compliance
– Supply Chain Management

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Board of Pharmacy Technician Specialties Launches with Three Certifications and 10 Certificates to Advance Technicians’ Careers

New NPTA initiative offering three advanced certifications, including CPhT-Adv, and ten certificates providing increased accessibility and affordability to advance the careers of pharmacy technicians and enhance patient care and pharmacy practice

HOUSTON, Jan. 18, 2022 /PRNewswire/ — The Board of Pharmacy Technicians Specialties (BPTS), an independent initiative of the National Pharmacy Technician Association (NPTA), today launched three new advanced certifications for pharmacy technicians, including the CPhT-Adv, and ten specialty certificates. These new offerings will increase accessibility to credentials that will validate the skills and knowledge for pathways to advance the careers of pharmacy technicians, enhance patient care, and strengthen the workforce for pharmacies.

NPTA has long been the industry leader in advanced training programs and specialty certifications for pharmacy technicians, such as their sterile compounding program where NPTA has trained and certified more than 13,000 individuals. BPTS’s new certifications and certificates expand on NPTA’s mission to support, educate, and advocate for pharmacy technicians.

Exams will be offered at just $49 and be open to individuals certified through either NHA or PTCB to ensure accessibility to career-advancing credentials to all certified pharmacy technicians. The exam fee will include one additional retake at no charge, providing significant value compared to industry alternatives. BPTS has also set eligibility requirements to be more closely aligned with those expected of board-certified pharmacists, where individuals are encouraged but not required to take specific training programs, so long as they have adequate work experience.

“The responsibilities placed on pharmacy technicians to respond to increased patient needs are greater than ever,” said Mike Johnston, CEO of the National Pharmacy Technician Association. “With the launch of BPTS and these new offerings, all certified pharmacy technicians will now have the ability to demonstrate their advanced skills and competencies, earn advanced credentials, and ultimately gain the recognition, respect and compensation they deserve.

Registration for the certifications and certificates is available now, and the first exams will be offered in mid-February. Pharmacy technicians may register today at www.bpts.org.