Global Pricing Insights – Last Week In Review – August 8 – 12, 2022

NAVLIN Brief

  • The U.S. Senate has passed the Inflation Reduction Act of 2022, which contains provisions aimed at lowering prescription drug costs in the U.S.The Act would allow Medicare to negotiate prescription drug prices, cap OOP spending for Medicare beneficiaries at $2,000 a year and extend subsidies to lower insurance premium costs that were first approved in the American Rescue Plan for another three years through 2025. The $35-a-month cap on insulin for private insurers was scrapped, although the House previously passed the Affordable Insulin Act, which would cap OOP spending on a month’s supply of insulin at $35 for all insurance plans.
  • Pfizer has agreed to acquire Global Blood Therapeutics (GBT) to the tune of $5.4 billion, or $68.50 a share. The deal gives Pfizer a more robust standing in the indication of sickle cell disease (SCD), as GBT is focused on discovering, developing, and delivering “life-changing” treatments that provide hope to underserved patient communities, starting with SCD.
  • After last week’s declaration of a public health emergency for monkeypox, U.S. Health and Human Services (HHS) Secretary, Xavier Becerra, has issued a measure to allow the U.S. Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines.

Details

COVID-19

The Japan Pediatric Society has recommended vaccinating healthy five to 17-year-olds with no previous or underlying medical conditions.

The South African Health Products Regulatory Authority (SAHPRA) has approved Janssen’s Covid-19 vaccine for adults as a single primary vaccination dose and also for use as a single booster dose.

On the recommendations made by the National Technical Advisory Group on Immunization (NTAGI), the interval between the second and the precaution dose of Covid-19 vaccines was revised from nine months to six months for all beneficiaries aged 18 years and above from July 6.

Based on the recommendations made by the Indian National Technical Advisory Group on Immunization (NTAGI), the interval between the second and the precaution dose of COVID-19 vaccines was revised from nine months to six months for all beneficiaries aged 18 years and above from July 6

 Policy

The U.S. Senate has passed the Inflation Reduction Act of 2022, which contains provisions aimed at lowering prescription drug costs in the U.S. The Act would allow Medicare to negotiate prescription drug prices, cap OOP spending for Medicare beneficiaries at $2,000 a year and extend subsidies to lower insurance premium costs that were first approved in the American Rescue Plan for another three years through 2025.

The New Mexico Department of Health’s (NMDOH) state-run All Payer Claims Database (APCD) will be fully operational in late 2023, announced the agency. The database is designed to bring more transparency to healthcare prices charged by providers and insurers, as well as monitor the growth of costs and improve quality. For the first time, the database is making publicly available these cost, quality, and other data.

A selection of drug companies and industry associations are banning together to build a “end-to-end world-class value chain” for developing cell and gene therapies in Australia.

A group of 10 leading institutions, charities, stakeholder groups, and life-science companies have put forward a number of asks and proposals to help drive more comprehensive use of biomarkers and more effective use of precision medicine for cancer patients in the UK.

Maria Cristina Abbate, STI/AIDS Coordinator in São Paulo said pharmacists can still prescribe PrEP and PEP within São Paulo. The government in July issued a notice against it, although Brazil’s chronic conditions and STI committee originally backed the measure. São Paulo accounts for 40% of all PrEP consumption in Brazil and Abbate wants to maintain wide access to treatment, especially since it’s “prevention,” not a “medical act” or “treatment”.

The MoU signed between Colombia and Denmark will have both parties working to improve health matters over the next five years. Key areas of focus include primary health care; prevention and promotion; noncommunicable diseases, with an emphasis on diabetes and mental health; drug surveillance, particularly AMR; and digital health.

The Indian Department of Pharmaceuticals (DoP) has released an updated list of 45 approvals it has issued to various companies under the Production Linked Incentive (PLI) scheme for the promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs), and active pharmaceutical ingredients (APIs).

HTA

The Scottish Medicines Consortium (SMC) has published advice on five newly licensed drugs for use by Scotland’s National Health Service (NHS), including Janssen’s orphan drug Darzalex (daratumumab) in combination with cyclophosphamide bortezomib and dexamethasone, for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis.

Novartis’ Tabrecta (capmatinib) has been denied early access authorization by France’s High Health Authority (HAS)— Tabrecta is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and platinum-based chemotherapy.

The Federal Joint Committee (G-BA) of Germany has determined that BieGene’s Brukinsa (zanubrutinib) added benefit is “not proven” for treating adults with Waldenström’s macroglobulinemia, who have received at least one prior therapy, or who cannot receive chemo-immunotherapy.

Germany’s Federal Joint Committee (G-BA) has found the added benefit of Zeposia (ozanimod) to be “not proven” for the treatment of adult patients with two variations of moderately to severely active ulcerative colitis; patients who have had an inadequate response to conventional therapy, no longer responding to it, or who have an intolerance or contraindication, and patients who have had an inadequate response to, are no longer responding to, or are intolerant to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor).

Price & Reimbursement

During its latest meeting, the Tariff Council of Azerbaijan approved the prices of 337 new state-registered medicines. The outcome of the meeting brings the complete list of medicines approved in Azerbaijan to 13,369.

At its latest meeting on August 10, Japan’s Central Social Insurance Medical Council (Chuikyo) added a new batch of drugs to the country’s national health insurance (NHI) price list.

The Panama health ministry has so far reviewed 108 products from a list of medicines and prices from Panama’s consumer watchdog agency, ACODECO. “Extensive discussions” between the ministry, industry, pharmacists, and patient groups have seen more products come under scrutiny.

Panama, from August 15, is applying a 30% discount to 170 medicines to resolve withstanding issues of availability and affordability. The Technical Table drew up the list of medicines on Medicines, and prices from June 30, 2022, were used to determine the discounts.

South Korea’s Health Insurance Review and Assessment Service’s (HIRA) cancer drugs committee backed reimbursement for Amgen’s Blincyto (blinatumomab) for treating B-cell acute lymphoblastic leukemia (ALL) positive for minimal residual disease.

BARDA seeks IV Tpoxx (tecovirimat) for monkeypox at a value of $26 million, with deliveries to be carried out by 2023 as per SIGA’s 19C contract with HHS.

400 vials of Biogen’s Spinraza (nusinersen) and 500 vials Roche’s Evrysdi (risdiplam) both landed in Iran this month for the treatment of SMA. Iran President Raisi and the Majles, Iran’s Parliament, have both spotlighted SMA as a disease for which health authorities should provide more medicine. Last year, Iran’s first SMA registry launched at Mofid Children’s Hospital—to date, Iran is home to 500 SMA patients.

Drug Approval

Although it initially received accelerated approval, Novartis’ Tabrecta (capmatinib) has now been granted regular approval from the U.S. FDA for the treatment of adults with non-small cell lung cancer (NSCLC) whose tumors have MET exon 14 skipping mutations (METex14), as detected by an FDA-approved test, with the availability of new data from GEOMETRY mono-1.

The FDA approved Enhertu from AZ and Daiichi Sankyo for adults with unresectable or metastatic HER2-low breast cancer treated with chemotherapy in the metastatic setting or who experienced disease recurrence after adjuvant chemotherapy.

Health Canada has approved AstraZeneca’s Lynparza (olaparib) for certain adult patients with HER2- early breast cancer treated with neoadjuvant or adjuvant chemotherapy.

Menarini Group, and its subsidiary, Stemline Therapeutics, announced that the U.S. FDA accepted the New Drug Application (NDA) for elacestrant, a novel treatment for ER+/HER2- advanced or metastatic breast cancer.

The U.S. FDA) awarded Fast Track Designation (FTD) to aTyr Pharma’s efzofitimod for treating pulmonary sarcoidosis, a major form of interstitial lung disease.

Incyte Biosciences has initiated a submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to extend its Pemazyre (pemigatinib) to include the treatment of FGFR1 fusion gene-positive myelogenous or lymphatic tumors.

Attralus, Inc. has bagged U.S. FDA Orphan Drug Designation (ODD) for AT-01 (iodine (I-124) evuzamitide) as a diagnostic for the management of transthyretin amyloidosis (ATTR).

 

The U.S. FDA has approved Bayer’s supplemental New Drug Application (sNDA) for Nubeqa (darolutamide), in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Bayer’s drug is now approved for both mHSPC and nmCRPC in men at risk of developing metastatic disease.

The Center for Drug Evaluation (CDE) under China’s national drug regulator – the National Medical Products Administration (NMPA) – accepted InnoCare’s supplemental New Drug Application (sNDA) for orelabrutinib for the treatment of relapsed or refractory Marginal Zone Lymphoma (R/R MZL)

Other

Pfizer has agreed to acquire Global Blood Therapeutics (GBT) to the tune of $5.4 billion, or $68.50 a share. The deal gives Pfizer a stronger standing in the indication of sickle cell disease (SCD), as GBT is focused on discovering, developing, and delivering “life-changing” treatments that provide hope to underserved patient communities, starting with SCD.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has placed drugs containing the active substance, Sorafenib in a new exchange group starting from September this year.

Patients are at risk, pharmacists warn, as supply issues are affecting hormone replacement therapy (HRT), osteoporosis and painkillers. The Department of Health and Social Care (DHSC) said it works “closely with industry, the NHS and others to prevent shortages and resolve any issues as soon as possible.”

People living with HIV are facing an acute shortage of antiretroviral (ARV) drugs, protesters claim who have been camping outside the National AIDS Control Organization (NACO) office in the Indian capital for the past 15 days.

Cancer patients in Scotland are set for faster access to treatment as Scotland’s Health Secretary Humza Yousaf announced that the Scottish government had allocated £10 million in funding to help improve waiting times.

Learn more about NAVLIN by EVERSANA and our Global Pricing Solutions.

Contact us with your questions and global pricing needs, and an expert will follow up shortly.