Industry Trends

Radar On Market Access: Payers Will Likely Use Various Tactics to Manage Zolgensma

June 11, 2019

With the first therapy north of $1 million gaining FDA approval last month, payers likely will implement a variety of strategies to manage Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene therapy from AveXis, Inc., a Novartis company. For now, many uncertainties exist with respect to the new treatment and what its place will be in spinal muscular atrophy (SMA) care, AIS Health reported.

With the first therapy north of $1 million gaining FDA approval last month, payers likely will implement a variety of strategies to manage Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene therapy from AveXis, Inc., a Novartis company. For now, many uncertainties exist with respect to the new treatment and what its place will be in spinal muscular atrophy (SMA) care, AIS Health reported.

According to Lee Newcomer, M.D., principal at Lee N. Newcomer Consulting LLC, payers likely will implement “strict enforcement of the label restrictions, advisory panels to develop clinical criteria for therapy [and] highly specific provider networks to ensure that the therapies are given correctly.”

When it comes to payer strategies, “unlike other conditions, where there might be alternatives that warrant prior authorization or step therapy, here I expect there to be limited management and more care coordination,” Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors, tells AIS Health.

“If I were a payer, I would definitely use prior-authorization for this, but given the nature of the therapy, you can’t use step edits — it doesn’t really make sense clinically,” says an industry expert who declines to be identified. “But prior authorization really needs to occur extremely quickly.”

“Plans will likely implement a medical policy to ensure appropriate use and ensure adequate monitoring,” says April M. Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC. “This is a one-time IV infusion; any repeated administration has not been evaluated and will likely not be covered until there is data to support that use.”

One concern among some payers is whether members will attempt to be treated with both Zolgensma and Spinraza (nusinersen), another expensive therapy for SMA. “It’s not clear yet if the combination or the sequence is better care until further studies are completed,” says Newcomer.

Trends That Matter for Use of Biologics

June 6, 2019

Almost 5.8 billion prescriptions were dispensed in the United States in 2018, an increase of 2.7% over the previous year, according to the IQVIA Institute for Human Data Science’s report Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023, AIS Health reported.

Almost 5.8 billion prescriptions were dispensed in the United States in 2018, an increase of 2.7% over the previous year, according to the IQVIA Institute for Human Data Science’s report Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023, AIS Health reported.

Retail and mail pharmacies dispensed 127 million specialty prescriptions last year, an increase of 15 million since 2014. In 2018, for the second year in a row, specialty prescription volume grew more than 5% although the medicines accounted for only 2.2% of prescriptions overall. With an increase in the availability of oral and self-injected specialty therapies, these drugs “are increasingly dispensed through retail pharmacies,” said Murray Aitken, executive director of the institute, during a May 6 press call.

The use of biosimilars — which the institute defines on a broader basis than only those therapies approved through the 351(k) pathway — “in terms of volume is still modest,” said Aitken, with these therapies representing less than 2% of the total biologics market in 2018. But in those areas where a biosimilar is available, “there is reasonably rapid uptake.”

Radar On Market Access: Oncology Is Experiencing Surge Of Innovation — and Prices

June 6, 2019

The oncology space continued its trend of developing innovative therapies — both those launching and in the pipeline — in 2018. That’s according to a new report from the IQVIA Institute for Human Data Science titled Global Oncology Trends 2019: Therapeutics, Clinical Development and Health System Implications. And while the outlook continues to look promising in terms of the science, it may pose issues to the health care system that need to be resolved in order to take full advantage of next-generation oncology products, AIS Health reported.

The oncology space continued its trend of developing innovative therapies — both those launching and in the pipeline — in 2018. That’s according to a new report from the IQVIA Institute for Human Data Science titled Global Oncology Trends 2019: Therapeutics, Clinical Development and Health System Implications. And while the outlook continues to look promising in terms of the science, it may pose issues to the health care system that need to be resolved in order to take full advantage of next-generation oncology products, AIS Health reported.

The 15 new oncology drugs and one supportive care drug launched last year for 17 tumor types marked a record. “Importantly, one of the new drugs is tissue-agnostic” — Loxo Oncology, Inc. and Bayer Corp.’s Vitrakvi (larotrectinib) — noted Murray Aitken, executive director of the institute, during a May 23 media call to discuss the report’s findings. “Over half of the new drugs are oral therapies, continuing this trend toward more of the targeted, innovative therapies being available in an oral form. Two-thirds of the new drugs have an orphan indication, continuing this trend towards cancer being redefined into narrower segments.”

Among the new drugs, more than half have a predictive biomarker on their label.

“This is a trend, the movement towards precision medicine and the growing role that predictive biomarkers are having, both in the way in which the drugs are tested in the clinic, as well as used in practice, where patients can be tested for a biomarker in advance of being treated with a particular drug,” maintained Aitken.

This level of innovation, however, has meant a surge in spending for these treatments.

Total spending on all oncology drugs, both therapeutics and supportive care products, globally was almost $150 billion, up 12.9% for the year, which “marks the fifth consecutive year of double-digit growth,” said Aitken.

In the U.S., “spending on cancer drugs has doubled since 2013 and exceeded $56 billion in 2018,” he noted.

Radar On Market Access: Blues Plans Promote Alternative Treatments to Combat Opioid Epidemic

June 4, 2019

Blues plans are promoting alternatives to opioids — and are seeing some increased uptake of alternatives such as acupuncture — but are hampered by employer policies that either don’t cover or place limits on many of those alternatives. Still, employers are showing interest in providing alternatives to opioids, plans say, and individual Blues plans are taking steps to update their coverage and encourage physicians to prescribe non-opioid chronic pain treatments, AIS Health reported.

Blues plans are promoting alternatives to opioids — and are seeing some increased uptake of alternatives such as acupuncture — but are hampered by employer policies that either don’t cover or place limits on many of those alternatives. Still, employers are showing interest in providing alternatives to opioids, plans say, and individual Blues plans are taking steps to update their coverage and encourage physicians to prescribe non-opioid chronic pain treatments, AIS Health reported.

Caesar DeLeo, M.D., executive medical director at Highmark Health, tells AIS Health that Highmark promotes Centers for Disease Control and Prevention guidelines for chronic pain management, which stress non-opioid treatments.

However, DeLeo points out that employer policies don’t cover some of the alternative therapies, which is a disincentive for patients facing chronic pain. “It’s at odds with the concept of keeping people off opioids,” he says. For example, acupuncture is covered under certain evidence-based guidelines, as is Botox for migraines, he says. Physical therapy, occupational therapy and chiropractic care also are covered, albeit with policy-set limits, and injections and non-opioid medications are covered, he says.

Independence Blue Cross covers mainstream therapies, says Ginny Calega, M.D., vice president of medical affairs. She also notes that employer groups have been interested in alternatives to opioids, and Independence has communicated with both members and physicians about these alternatives.

Blue Shield of California has seen an uptick in the use of alternative treatment modalities for chronic pain, including physical therapy and acupuncture, although it’s not clear this is instead of opioids or in addition to opioid prescriptions, says Salina Wong, Pharm.D., director of clinical pharmacy programs.

Radar On Market Access: CMS ‘Meaningfully Walks Back’ on Key Drug Pricing Proposals

May 28, 2019

When CMS issued the final rule on Medicare Advantage and Part D drug pricing on May 16, the agency touted its policy changes as ensuring consumers get greater transparency into the cost of Part D prescription drugs and enabling MA plans to negotiate better prices for physician-administered medicines in Part C. Yet, after receiving 4,000-plus comments related to pharmacy price concessions on negotiated price, CMS held back, saying it won’t implement this policy for 2020 — or follow through on proposed exceptions to Part D protected drug classes, AIS Health reported.

When CMS issued the final rule on Medicare Advantage and Part D drug pricing on May 16, the agency touted its policy changes as ensuring consumers get greater transparency into the cost of Part D prescription drugs and enabling MA plans to negotiate better prices for physician-administered medicines in Part C. Yet, after receiving 4,000-plus comments related to pharmacy price concessions on negotiated price, CMS held back, saying it won’t implement this policy for 2020 — or follow through on proposed exceptions to Part D protected drug classes, AIS Health reported.

Among numerous provisions, CMS’s final rule implements the statutory prohibition against gag clauses in pharmacy contracts, barring Part D plans from penalizing pharmacies that disclose a lower cash price to enrollees. But the agency decided against implementing a policy redefining negotiated price as the lowest possible, baseline payment to pharmacies.

Leerink analyst Ana Gupte sees industry winners across the board. CMS “did not follow through on its proposal to exclude certain protected drug classes, offering a win for the biopharma industry,” she said in a May 17 note. “Managed Care and PBMs also garnered a win as CMS did not follow through on the proposals to pass through pharmacy pricing concessions in the form of DIR [direct and indirect remuneration] fees to patients through reduced cost sharing.”

Dea Belazi, Pharm.D., president and CEO of AscellaHealth, offers a blunter assessment. “I think the final Part D rule is more rhetoric than anything,” he tells AIS Health.

As for negotiated price, “They’re not ready to do anything on pricing at this point,” Belazi says. “I think CMS, with HHS, opened up a Pandora’s box and realized this is not as easy as it seems and they need more time.”

Trends That Matter for Infliximab Biosimilars

May 23, 2019

Magellan Rx Management saw a significant shift in utilization from Janssen Biotech, Inc.’s Remicade (infliximab) to biosimilars after it implemented a comprehensive utilization management (UM) program, resulting in 34% drug cost savings, the PBM reported.

Magellan Rx Management saw a significant shift in utilization from Janssen Biotech, Inc.’s Remicade (infliximab) to biosimilars after it implemented a comprehensive utilization management (UM) program, resulting in 34% drug cost savings, the PBM reported.

The program, which began in late 2017, involves any patient prescribed an infliximab product for any indication, and is available to all payer clients as an opt-in option, Steve Cutts, senior vice president and general manager, tells AIS Health.

When Magellan Rx began the infliximab program in the fourth quarter of 2017, 100% of the PBM’s patients receiving an infliximab product received Remicade and none took biosimilars, the PBM said. In the third quarter of 2018, the last quarter for which Magellan has data, 86% of patients got the biosimilar and 14% took the brand-name drug.

The FDA approved the first infliximab biosimilar, Pfizer, Inc.’s Inflectra (infliximab-dyyb), in April 2016. The agency now lists three approved infliximab biosimilars: Inflectra; Merck & Co., Inc.’s Renflexis (infliximab-abda); and Pfizer’s Ixifi (infliximab-qbtx). Pfizer is not launching Ixifi in the U.S. since it already has Inflectra on the market, so only Inflectra and Renflexis are being sold in the U.S.

Below is the current market access to Remicade, Inflectra and Renflexis under the pharmacy benefit: