Spotlight on Market Access

More Cancer Indications With Accelerated Approval Are Being Withdrawn

Three more oncology indications given accelerated approval are being withdrawn from the U.S. market at the request of the FDA. Those mark just shy of 20 oncology indications and/or drugs that have been approved through that accelerated pathway and then subsequently retracted since 2020. While accelerated approval may be benefiting patients with nononcology indications, its track record for oncolytics is not quite as impressive, says one industry expert.

Most recently, Roche said on Nov. 29 that it was voluntarily withdrawing Tecentriq’s (atezolizumab) indication for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express programmed death-ligand 1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The agency granted accelerated approval for that indication on April 17, 2017, to Roche’s Genentech USA, Inc. subsidiary.


Customer Satisfaction With PBMs Drops to a Three-Year Low, Study Reports

Plan sponsors’ overall satisfaction with their PBMs was 7.8 on a 1-10 scale in 2022, down from 8.2 last year, according to Pharmaceutical Strategies Group’s 2022 Pharmacy Benefit Manager Customer Satisfaction Report. The report was based on surveys completed by 236 individuals representing employers, unions/Taft Hartley plans, health plans and health systems that covered an estimated 76 million lives. Respondents reported a lower likelihood to recommend their PBM to a colleague or to renew their contract without issuing a competitive request for proposal this year, highlighting costs as the primary driver to leave the PBM.

Among core PBM services, satisfaction was highest for “offering competitive traditional drug discounts” and “meeting financial guarantees.” As clinical and cost management programs play a key role in reducing overall costs, 82% of respondents reported using utilization management, while only 8% used gene therapy financial protection programs.


IRA, Uncertainties Within Law May Be Challenging for Biopharma

The Inflation Reduction Act (IRA) will allow Medicare to negotiate prescription drug prices, starting with a limited set of therapies in 2026. But while some aspects of the law are clear, some uncertainties around others exist. Biopharma companies need to start preparing as much as they can for some of the challenging situations that may arise, recommends one industry expert.

Josh Schimmer, an analyst at Evercore ISI, pointed out during a Nov. 17 webinar hosted by his company that the IRA has “many, many moving parts, some of which are…really quirky, some of which seem a little unsustainable in terms of the dynamic that they might have. It’s going to impact so many companies in this industry sooner or later; some might be spared. But those are probably going to be smaller companies. So the bigger you are, the more likely you are at some point to have to face the IRA.”


MMIT Payer Portrait: Sanford Health Group

Sanford Health Group is the health insurance unit of Sanford Health, a large, integrated nonprofit health system of 47 hospitals based in Sioux Falls, South Dakota. It is the second-largest insurer in both its home state and neighboring North Dakota and also has a presence in Iowa, Minnesota and Nebraska. Sanford largely serves the commercial health insurance markets, having a strong presence in both the North and South Dakota exchange markets. The majority of its members are enrolled in risk-based commercial insurance products. UnitedHealth Group’s OptumRx serves as Sanford’s pharmacy benefits manager and also facilitates most of its specialty pharmacy benefits.


Payer Lobbying May Pale Next to Pharma, but Experts Say Industry Still Packs Clout

While lobbying expenditures from the health care industry have been rising in recent decades, drugmakers and providers — not insurers — are the main drivers of that spending growth, according to recent research. Still, experts tell AIS Health, a division of MMIT, that the managed care sector’s influence over policy shouldn’t be underestimated.

“Overall, the fact that the industry keeps lobbying means that this investment has some good return; otherwise, they would have stopped,” says Ge Bai, Ph.D., a professor at Johns Hopkins University’s schools of business and public health.


Health Care Lobbying Rose 70% in 20 Years

Lobbying spending by the health care industries reached $713.6 million in 2020, a 70% increase over the past two decades, according to a recent JAMA Health Forum analysis based on data compiled by OpenSecrets. The growth was mainly driven by pharmaceutical and health product manufacturers and providers. Expenditures were highly concentrated among a small subset of firms, especially for payers, with the top 10% of health plans responsible for 70.4% of spending.


Collaboration Is Needed Among Stakeholders for Genetic Tests to Be Beneficial

As researchers gain growing insight into the mechanics of what makes diseases tick, more and more genetic tests are coming onto the market to help make sure the right patient gets the right drug at the right time. While these diagnostics can help inform diagnosis and treatment for patients, the sheer volume of these tests may be overwhelming payers in their coverage decisions. Stakeholders should work together to help establish the clinical utility that payers need to make coverage decisions on these diagnostics, industry experts say.

Daryl Pritchard, Ph.D., senior vice president of science policy at the Personalized Medicine Coalition (PMC), describes the landscape of coverage for genetic testing as “uneven. Payers are increasingly considering coverage and reimbursement of genetic testing products and services.” However, he tells AIS Health, a division of MMIT, “there remain significant challenges in establishing coverage policies and payment rates for diagnostic tests that reflect the value of their care. As a result, many newer novel diagnostics are under-reimbursed or not covered at all. Such practices ultimately restrict patient access to some needed tests and to optimal care. Coverage and reimbursement policies vary widely among different payers, and decision-making processes are often inconsistent and not transparent.”


NSCLC Boasts Multiple Targeted Therapies, but Many Patients Are Not Benefiting From Them

The FDA has approved around 100 targeted therapies for different types of cancer, with many more in the pipeline. Current agents for non-small cell lung cancer (NSCLC), for example, target more than 10 different biomarkers, and more than 70% of people with the condition have alterations in their tumors that are tied to available treatments. But a recent study found that due to practice gaps in the precision oncology pathway, just more than one-third of patients with biomarkers that could be treated with an FDA-approved therapy are actually benefiting from those drugs.

Lung cancer is one of the most common types of cancer, and NSCLC makes up the bulk of the cases. Many of the agents approved for NSCLC are targeted therapies that are indicated for specific subsets of the disease, and numerous companion diagnostic tests are available to help providers determine the best treatment for a patient.


In Executive Order, Biden Directs CMMI to Tackle Drug Costs

In an executive order released Oct. 14, the Biden administration directed the CMS Center for Medicare and Medicaid Innovation (CMMI) to “to consider additional actions to further drive down prescription drug costs,” building on the Medicare drug price negotiation stipulations of the Inflation Reduction Act (IRA). D.C. insiders tell AIS Health, a division of MMIT, that CMMI could pull old policy proposals off the shelf when it works to “test new ways of paying for Medicare services that improve the quality of care while lowering costs,” as the administration puts it.

The executive order isn’t specific about what policies the White House would prefer CMMI look into. However, the administration will know the possibilities fairly soon: CMMI will have 90 days to develop recommendations. Per a White House fact sheet, the final product will be “a formal report outlining any plans to use the Innovation Center’s authorities to lower drug costs and promote access to innovative drug therapies for Medicare beneficiaries.”


Employer Plans in 2022: Premium Growth Remains Steady, Mental Health Concerns Employers

The average annual premium for employer-sponsored health insurance in 2022 was $7,911 for single coverage and $22,463 for family coverage, similar to the average premiums last year, according to the Kaiser Family Foundation 2022 Employer Health Benefits Survey. On average, employees contributed 17% toward single coverage premiums and 28% toward family coverage premiums. Among employees at small firms, 33% of them chose a plan where the employer paid the entire premium for single coverage, compared with only 6% at large firms. Meanwhile, 31% of small firm workers were in a plan that required them to contribute more than half of the premium for family coverage.