Data & Analytics

Trends That Matter for COPD Medications

June 20, 2019

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

Advair Diskus, a combination long-acting beta-agonist and an inhaled corticosteroid, has been one of the most common drugs used for COPD, a condition largely dominated by brand products. The generic, marketed by Mylan and approved Jan. 30, joins generics for two additional COPD devices: a generic for Ventolin HFA (albuterol) and one for Proair HFA (albuterol).

All three have the potential to save payers and patients significant money. Charline Shan, R.Ph., vice president, access experience team at payer insights and strategy firm Precision for Value, says plans have multiple options for structuring their formularies with the amount of generic options available.

Generics are typically included, with brand drugs placed on preferred or nonpreferred tiers based on price, “but not all are required or have to be on the formulary since there are many branded and therapeutic equivalent options,” she says.

Below is the current market access to COPD medications under the pharmacy benefit:

Perspectives on CMS’s Drug Pricing Proposals

June 13, 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 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: 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: