Cost Effectiveness

Industry says it is ready to work with the government on the recommendations from a major review of Australia’s health technology assessment system that covers areas such as discount rate reductions and setting up a separate budgetary allocation to temporarily subsidize access to certain drugs.

Cost watchdog NICE has blocked Leqembi’s use, but a pricing deal could unlock access to the beta-amyloid targeting drug

Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.

While the drug regulator has approved Eisai/Biogen’s early Alzheimer’s disease treatment, the health technology assessment institute is worried that its benefits are too small to justify its costs – a concern that Eisai has pledged to address.

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.

The Dutch health technology assessment institute, ZIN, has called for a debate on how society should tackle obesity and whether expensive treatments should be part of the national prevention strategy.

Sanofi, Alexion and Eli Lilly argue for changes in England’s health technology assessment and medicine pricing processes that could help patients to access more medicines.

The rolling reimbursement reviews that Canada’s Drug Agency introduced as a pilot scheme to speed up patient access to COVID-19 products can now be used for any drug application. The move to open up the mechanism follows prompts by industry.

Since 2019, 91 health technology assessments have been terminated by England’s NICE because companies withdrew their applications or did not submit evidence. In the first of this three-part article series, pharma firms share their reasons for opting out of the process.

England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.

The CDC’s ACIP again punted a decision on whether to make a pneumococcal vaccine available to all adults 50 and older amid concerns over cost and equity tradeoffs, as well as unknowns about the length of vaccine protection. 

Two targeted treatments for six different types of cancer and two antifungal drugs are the first products that Pharmac has proposed should be funded after it received a boost to its budget in June. Separately, the government is seeking feedback on a bill to repeal the sweeping new therapeutic products law that was passed by its predecessor.

England’s NICE should factor in the impact of patent expiry on future drug prices when analyzing the cost effectiveness of new medicines and should also take account of societal benefits, a group of health economists has said.

Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.