PRICENTRIC BRIEF
- Germany’s largest statutory health insurance fund, AOK, has negotiated rebates of more than 99% for some generics, according to confidential documents seen by Apotheke Adhoc — the insurer inadvertently sent confidential documents containing details of discounts offered by Glenmark, an Indian drug manufacturer involved in the tender, to competitors
- The U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), 10 pharmaceutical companies and five non-profit organizations have launched the Bespoke Gene Therapy Consortium (BGTC) to accelerate the development of gene therapies for Americans who suffer from rare diseases — the consortium’s primary aim is to improve understanding of the gene delivery vector known as adeno-associated virus (AAV), specifically the biological and mechanistic steps involved in AAV production, vector delivery of genes into human cells and how therapeutic genes are activated in target cells
- Claiming it plans to “wind down” operations in Europe to focus on its presence in the U.S., bluebird bio has withdrawn its application for the reimbursement of Zynteglo (betibeglogene autotemcel) via the BeNeLuxa initiative
THE DETAILS
COVID-19
The Centers for Disease Control and Prevention (CDC) has endorsed the U.S. Food and Drug Administration’s (FDA) emergency authorization for Moderna and Johnson & Johnson’s COVID-19 vaccines for booster doses.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has concluded that a booster dose of Moderna’s Spikevax COVID-19 vaccine may be considered in people age 18 years and older.
The European Commission (EC) has published a list of 10 COVID-19 treatment candidates likely to be authorized in the near future. A group of independent scientific experts screened 82 therapeutic candidates in late-stage clinical development, taking into account the need for different types of products for different patient populations and at different stages and severities of the disease. The expert group did not consider manufacturing, production volumes, prices or access conditions in their selection process.
POLICY
The U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), 10 pharmaceutical companies and five non-profit organizations have launched the Bespoke Gene Therapy Consortium (BGTC) to accelerate the development of gene therapies for Americans who suffer from rare diseases. The consortium’s primary aim is to improve understanding of the gene delivery vector known as adeno-associated virus (AAV), specifically the biological and mechanistic steps involved in AAV production, vector delivery of genes into human cells and how therapeutic genes are activated in target cells.
The Danish Medicines Agency has announced that as of January 1, 2022, it will be able to recommend drugs conditionally for a limited period of time and will be introducing off-label use of certain drugs.
Various health industry bodies in France are proposing concrete measures to help guarantee “sustainable health safety and autonomy,” based on vulnerabilities identified in a PwC report.
The European Medicines Agency (EMA) has reached an agreement on a draft research framework for the inclusion of patient views in its regulatory decisions. The agency has now opened a public consultation on the draft framework, which will run until November 25, 2021.
The FDA has published draft guidance for the pharmaceutical industry containing its advice on how a sponsor should submit drug and biological product study data from real-world data (RWD) sources.
PRICING & REIMBURSEMENT, HTA
Claiming it plans to “wind down” operations in Europe to focus on its presence in the U.S., bluebird bio has withdrawn its application for the reimbursement of Zynteglo (betibeglogene autotemcel) via the BeNeLuxa initiative.
Germany’s largest statutory health insurance fund, AOK, has negotiated rebates of more than 99% for some generics, according to confidential documents seen by Apotheke Adhoc. The insurer inadvertently sent confidential documents containing details of discounts offered by Glenmark, an Indian drug manufacturer involved in the tender, to competitors.
The National Institute for Health and Care Excellence (NICE) has turned down reimbursement of Seagen’s Tukysa (tucatinib) with trastuzumab and capecitabine for treating HER2-positive locally advanced or metastatic breast cancer in adults after at least two prior anti-HER2 treatment regimens.
A new pharmacy benefit manager (PBM) has been launched by Purchaser Business Group on Health (PBGH), a nonprofit coalition of public healthcare purchasers and large, private employers, including Walmart and Costco. EmsanaRx, the first business unit of Emsana Health, aims to “address the concerns of many U.S. employers that the healthcare services they buy are of uncertain quality and exorbitantly priced,” says a press release from PBGH.
DRUG APPROVAL
The U.S. FDA announced on Thursday it will withdraw 216 applications, as the relevant manufacturers “repeatedly” did not submit the necessary reports for the applications to be accepted. The decision follows a notice of opportunity for hearing (NOOH) that the FDA published in January 2020, which listed 249 applications from 89 manufacturers with “delinquent annual reports.” Read the official notice containing the list of applications here.
The European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD- L1 with a combined positive score (CPS) ≥ 5.
The EC has approved Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease.
The U.S. FDA and EMA have accepted Novartis’s supplemental Biologics License Application (sBLA) and Type II Variation, respectively, for CAR-T therapy Kymriah (tisagenlecleucel) in adults with relapsed or refractory (r/r) follicular lymphoma (FL) after two lines of treatment.
BIOSIMILARS
The Center for Biosimilars said an additional 1.2 million patients may benefit from biosimilars by 2025, referencing a specialty pharmacy report by CoverMyMeds, a division of McKesson. While 21 biosimilars are currently on the U.S. market, the report says, access is limited due to inconsistent manufacturer rebates and discounts and lack of price transparency.
Boehringer Ingelheim (BI) has obtained two interim injunctions against Dr. Reddy’s Labs and MSN Labs, two India-based drugmakers that recently launched low-priced generic versions of BI’s Jardiance (empagliflozin). BI currently holds a valid product patent in India until 2025, which should prevent the two domestic manufacturers from launching, making, selling, importing and/or exporting their respective generic versions of empagliflozin.
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