Global Pricing Insights – Last Week In Review – Oct 18 – 22, 2021

PRICENTRIC BRIEF

  • The FDA has approved the supplemental Biologics License Application (sBLA) for Boehringer Ingelheim’s Cyltezo, making it the first interchangeable biosimilar with Humira (adalimumab). Cyltezo was initially given the FDA greenlight in 2017 for the treatment of multiple chronic inflammatory diseases, but the latest approval designates it as officially “interchangeable” across all of these indications
  • The Institute for Clinical and Economic Review (ICER) released its Final Evidence Report assessing the comparative clinical effectiveness and value of Alexion’s Soliris (eculizumab) and efgartigimod for the treatment of generalized myasthenia gravis (gMG)— in the report, ICER’s health-benefit price benchmark (HBPB) for Soliris is $13,200-$19,400 per year, a range that would require at least a 97% discount off the treatment’s current U.S. list price
  • Novartis announced that it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent (LOI) for Zolgensma (onasemnogene abeparvovec)— the negotiation means that individual public drug plans in Canada can now make final decisions about the coverage and availability of the gene therapy

THE DETAILS

COVID-19

The U.S. Food and Drug Administration (FDA) has granted emergency authorization to Moderna and Johnson & Johnson’s COVID-19 vaccines for booster doses, as well as clarifying that those who have boosters can mix and match compared to their original shots.

Gilead announced on Monday that its COVID-19 treatment Veklury (remdesivir) is now available through Japan’s normal distribution channel, reported Pharma Japan. The announcement came roughly two months after the drug’s addition to the National Health Insurance (NHI) price list in August. Veklury received special emergency approval in May of last year.

The Bill & Melinda Gates Foundation has announced it will provide up to $120 million to speed up access to Merck’s investigational COVID-19 antiviral pill, molnupiravir, for lower-income countries.

The Access to COVID-19 Tools Accelerator (ACT-A), led by the World Health Organization (WHO), is planning to purchase antiviral drugs for patients with mild COVID-19 symptoms for as little as $10 per course, says a draft document seen by Reuters.

Ahead of the G20 meeting in Rome at the end of this month, the WHO and the Association of Innovative Medicines (VIG) are calling on world leaders to facilitate fair access to COVID-19 vaccines. The VIG said the onus is on governments since manufacturers have already done their part, forming more than 300 partnerships to broaden vaccine production in addition to working with the COVAX facility among other organizations involved in distribution. Meanwhile, the WHO asked the G20 leaders to arrange for donations of vaccine doses to the global south, reported Reuters. “The @g20org countries must fulfil their dose-sharing commitments immediately,” WHO director-general Tedros Adhanom Ghebreyesus told a news briefing.

POLICY

The Committee for the Evaluation of Oncological Resources in the Netherlands has proposed new criteria for treatments that received a conditional marketing authorization on the basis of studies without a control group.

The German Federal Ministry of Health, the Federal Social Security Office and the National Association of Statutory Health Insurance Funds have forecast that next year the statutory health insurance (GKV) will potentially have additional financial requirements of EUR 7 billion.

The Ukrainian Cabinet of Ministers has approved an action plan for the development of the System of Medical Care for Patients Suffering from Rare (Orphan) Diseases, set to be implemented from 2021-2026. Minister of Health Viktor Lyashko noted on its release that the plan should help solve a number of organizational issues in reference, or expert, health care facilities so that medical services for patients with orphan diseases are provided more efficiently and comprehensively.

PRICING & REIMBURSEMENT

The Centers for Medicare & Medicaid Services (CMS) published the 2022 Star Ratings for Medicare Advantage (Medicare Part C) and Medicare Part D prescription drug plans. These ratings, which are released annually, act as a guide to compare Medicare plans ahead of the October 15 open enrollment start date.

Novartis announced that it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent (LOI) for Zolgensma (onasemnogene abeparvovec). Novartis applauded the government of Quebec’s decision to provide public reimbursement for Zolgensma under the Régie de l’assurance maladie du Québec (RAMQ) for the treatment of children with SMA. The negotiation means that individual public drug plans in Canada can now make final decisions about the coverage and availability of the gene therapy.

As Japan’s health ministry prepares the FY2022 medicines price revision, wholesalers predict the average gap between NHI prices and market prices will be similar to or below the 8.0% discrepancy rate from the last poll, reported Pharma Japan. This new prediction comes from a survey regarding drug purchases in September of this year.

BIOSIMILARS 

The European Medicines Agency (EMA) has released a report detailing the findings from its biosimilar scientific advice pilot. The pilot, which was launched in February 2017 and ran until April 2020, was a tailored scientific advice pilot to explore further in practice the approach to development support for new biosimilar developments. The pilot was open to all types of biosimilars and applicants and ran until the completion of six scientific advice requests. In April 2020, the pilot was completed with the finalization of the sixth procedure.

The FDA has approved the supplemental Biologics License Application (sBLA) for Boehringer Ingelheim’s Cyltezo, making it the first interchangeable biosimilar with Humira (adalimumab). Cyltezo was initially given the FDA greenlight in 2017 for the treatment of multiple chronic inflammatory diseases but the latest approval designates it as officially “interchangeable” across all of these indications.

DRUG APPROVAL

The FDA announced it has approved Genentech’s Tecentriq (atezolizumab) as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

Gilead announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

Dr. Reddy’s Laboratories announced the FDA has approved the Abbreviated New Drug Application (ANDA) for its generic version of Revlimid (lenalidomide).

HTA

The Institute for Clinical and Economic Review (ICER) released its Final Evidence Report assessing the comparative clinical effectiveness and value of Alexion’s Soliris (eculizumab) and efgartigimod (argenx, Halozyme Therapeutics, and Zai Lab) for the treatment of generalized myasthenia gravis (gMG). In the report, ICER’s health-benefit price benchmark (HBPB) for Soliris is $13,200-$19,400 per year, a range that would require at least a 97% discount off the treatment’s current U.S. list price. The final report states that Soliris’ annual net price is currently $653,100.

The National Institute for Health and Care Excellence (NICE) has recommended the use of Pfizer’s Xeljanz (tofacitinib) for treating active polyarticular juvenile idiopathic arthritis (JIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) and juvenile psoriatic arthritis in people 2 years and older.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has released a health economic assessment of Enhertu (trastuzumab deruxtecan) for the treatment of HER2-positive metastatic breast cancer patients who cannot be operated on and who have previously received two or more types of treatments aimed at HER2.

NICE has recommended the use of Givlaari (givosiran) for the treatment of acute haptic porphyria (AHP).

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