This Week in Managed Care: August 9, 2019

CMS gives chimeric antigen receptor (CAR) T-cell payments a boost, a US task force says those at risk for pancreatic cancer should be screened, and FDA says Novartis withheld data about a high-cost gene therapy.

Welcome to This Week in Managed Care, I'm Laura Joszt.

CMS Boosts CAR T Payments, Adjusts Hospital Wage Index

After waiting more than a year, cancer centers that offer CAR T-cell therapy learned that CMS will boost Medicare payments for the life-saving treatment, but only for 2 years. The new rates take effect October 1. The final plan will raise the marginal rate for a technology add-on payment from 50% to 65%, raising questions about what happens next.

CMS said in a statement: "The increased payment from 50% to 65% will promote patient access and reduce uncertainty that innovators face about Medicare payment for new medical technologies."

Some providers were pleased but others will wait and see. Hematologist/oncologist Joseph Alvarnas, MD, who serves as the point person on CAR T-cell therapy reimbursement for the City of Hope, told The Washington Post, "For now, this should probably be viewed as a step forward, but ani ncremental (rather than decisive) one."

CMS also finalized Medicare payment policies for rural and urban policies for the next fiscal year by updating the inpatient hospital wage index. Asminitrator Seema verma said that wage boost should help rural hospitals attract better talent and increase patient choice. CMS hopes to halt the alarming rate of hospital closures in rural areas.

For more, visit ajmc.com.

USPSTF Updates Recommendation on Pancreatic Cancer Screening

Pancreatic cancer is the fourth-leading cause of cancer death and one of the most frustrating diseases for oncologists, because patients often have no symptoms early on. But the US Preventive Services Task Force (USPSTF) said this week that screening the whole population still does not make sense due to the risk of too many false positives and the chance of doing more harm than good. However, the task force did update its language in the recommendation, and those with certain genetic risks or family history would benefit from screening.

The Pancreatic Cancer Action Network took note of the change. In a statement on its website, the advocacy group said, "USPSTF has made an important change to its definition of the 'general population.'"

An editorial in JAMA Surgery said the task force's "D" recommendation was no unexpected but that there's plenty of hope in the report's acknowledgement of useful biomarkers. Authors wrote: "Populations with significantly increased risk can now be targeted for screening, greatly increasing their positive pretest probability."

Novartis Concealed Manipulated Data About Gene Therapy

FDA chastised Novartis this week, saying the pharmaceutical giant concealed manipulated data about a $2 million gene therapy called Zolgensma, which treats a rare condition called spinal muscular atrophy. FDA said the company withheld the data while applying for approval, which would have delayed its approval. The issue involved mice treated with 2 different strengths of therapy. The product is staying on the market.

FDA's statement read in part: "The FDA is carefully assessing this situation and remains confident that Zolgensma should remain on the market. Out of the large amount of submitted information reviewed by the agency, our concerns at this time are limited to not only a small portion of the product testing data that was contained in the marketing application. However, the integrity of the product testing data used in the development of the product's manufacturing process is still a matter that we are continuing to evaluate and take very seriously."

A single dose of the human papillomavirus (HPV) vaccine can be effective in preventing cervical cancer, a recent study has found. The journal Papillomavirus Research reported that women in Australia health registry who had a single HPV dose at a young age were 35% less likely to develop precancerous lesions, compared with those who had all 3 doses who were 41% less likely to have lesions.

Lead author Julia Brotherton, MPH, of the University of Melbourne, said the results give weight to the idea of using single dosing strategies where cost and convenience are major issues.

She said, "The HPV vaccine has proven itself to be both very safe and remarkably effective."

Brotherton said the results must be validated in clinical trials.

For more, visit ajmc.com.

The Biosimilars Council Says Patent Abuses Are Costing Biosimilar Savings

Finally, our sister site The Center for Biosimilars^® this week features a podcast with Christine Simmon, executive director of the Biosimilars Council. Simmon discusses a white paper the Council produced as part of the Association of Accessible Medicines, which found that the patent system is delaying competition and costing the US healthcare system $7.5 billion in lost savings since 2015.

You can listen to the podcast here. For more, visit Centerforbiosimilars.com.

For all of us at the Managed Markets New Network, I'm Laura Joszt. Thanks for joining us.