Trump administration reports progress in lowering drug prices, while AMA, AAFP, await word on their proposals

President Donald J. Trump’s administration’s plan to lower drug prices — a 44-page document it calls the American Patients First Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs — has achieved results since its launch earlier this year, according to an HHS press release.

Lowering drug prices was one of the pledges then-candidate Trump made during his campaign.

The administration’s report on its efforts came shortly after the end of the public discussion period for a set of initiatives to lower drug prices from HHS. Several medical societies, including the American Academy of Family Physicians and AMA, submitted proposals and now wait to see if their suggestions were incorporated into the final rule. 

‘Unprecedented’ number of actions

“The President’s blueprint for lower drug prices is working, drug prices are coming down, and American patients are going to see the savings in their pocketbook,” HHS Secretary Alex Azar said in the release.

“At the time of the release of the blueprint, few observers believed that, within months, drug manufacturers would begin to change their annual ritual of significant price hikes. Yet that is what happened in the months following,” Dan Best, a senior advisor to Azar said in the release.

Pill Bottles
President Donald J. Trump’s administration’s plan to lower drug prices — a 44-page document it calls the American Patients First Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs — has achieved results since its launch earlier this year, according to an HHS press release.

Photo source: Shutterstock

 

Best and HHS noted these “unprecedented” actions since the blueprint was introduced on May 11:

  • 126 generic drugs approved in July;
  • 13 drug companies said they will not raise prices for the remainder of 2018;
  • 4 drug companies cancelled price increases;
  • 2 drug companies lowered drug prices;
  • 20 million seniors enrolled in Medicare Advantage have new negotiation tools;
  • A process that expedites development and review for products without market competition was implemented;
  • Proposals to drop payments for certain discounted drugs; to discourage both private-sector and pharmacist gag clauses; and to eliminate drug company Medicaid rebates moved forward;
  • Initiatives such as the Biosimilar Action Plan; promote competition and access to drugs; and address drug price spikes introduced;
  • Waiver to allow states to negotiate pricing contracts with drug makers granted;
  • Guidance to help insurers and drug companies “reach better deals” for patients provided;
  • Individual drug price increases displayed on CMS’s drug pricing dashboard; and
  • Comments on ways to use private-sector competitive acquisition for Medicare Part B drugs solicited.

Societies weigh in

The AMA and American Academy of Family Physicians were among the more than 3,000 individuals or organizations that offered feedback on the blueprint earlier this summer during the public comment period.

James L. Madara , MD, AMA CEO and executive vice president, said the Association “strongly supports” mandating pharmaceutical supply chain transparency; speeding up and expanding regulatory action to increase pharmaceutical market competition and fight anti-competitive practices; assuring prescribers have correct point-of-care coverage and patient cost-sharing information as part of their workflow, particularly a patient’s electronic health record; and making sure federal programs and commercial practices billed as lowering prescription medication prices do so for patients directly.

But he also wrote AMA cannot support a proposals that would financially penalize physicians and pharmacists for high cost prescription medications; increase patient costs; or initiate insurer paperwork requirements that hinder timely patient access to affordable and medically necessary medications and treatments.

He discussed the toll high drug prices take on the medical community and their patients.

“Physicians experience and see first-hand the difficulty and burden high pharmaceutical costs have imposed on our patients, on physician practices, and the broader health care system,” Madara wrote.

“Patients are increasingly taking greater clinical risks when treatments are cost-prohibitive. When patients delay, forgo, or ration their medication, their health status may deteriorate. Patients who cannot afford their medication will eventually require medical interventions in more costly care settings, such as emergency departments, when their condition is at a more advanced stage of disease,” he added. “These price increases continue to occur among all segments of the market from innovator biologics to previously low-cost established generics. Physicians see every day that costs have become a major barrier to our patients getting the right medication at the right time.”

Madara’s letter also provided anecdotes from patients, medical students and practicing and retired medical professionals to illustrate each group’s respective concerns about the current drug pricing system.

John Meigs, Jr., MD, FAAFP , and AAFP board chair, said the administration should consider increasing access to generic drugs; address off-patent drugs; contemplate further expansion of the site-neutral payments for outpatient services in regards to physician-administered drugs; explore value-based drug pricing; provide Medicare negotiation authority; and engage in “prevention first” practices, measures that Meigs said would ensure the availability of what he called “effective, safe, and affordable” prescription medications.

“Managing prescription drug prices for their patients is an important concern for family physicians,” he wrote in the AAFP response to the HHS proposal.

“Family physicians have a meaningful interest in the drug pricing debate, in part because of the complexity of care provided and the fact that the number and complexity of conditions, complaints, and diseases seen in family medicine is far greater than those seen by any other physician specialty. Ensuring access to medications is an integral part of a physician’s role as an advocate for their patients,” Meigs added.

Michael Munger, MD, president of the AAFP, told Healio Family Medicine, that many of the things that AAFP has been asking for regarding drug pricing are beginning to be addressed.

AAFP recognizes that the FDA has expedited the development and review of generic drugs that lack competition and has increased approvals of generic drugs, which is a positive, he said.

“AAFP has called for value-based pricing models that would link payment for drugs to more outcomes and cost effectiveness rather than pure volume of sales,” he said. So, the CMS waiver for states to negotiate value-based contracts with drug makers is a step in the right direction, according to Munger.

Allowing the Medicare advantage plans to have tools to negotiate prices for part B drugs is another move in the right direction, but the AAFP would still like to see the ability to negotiate for part D drugs, he said.

To further its progress, the administration should establish a site-neutral payment for physician-administered drugs, which would allow for good cost transparency and impact overall prices and restrict patent evergreen practices, according to Munger.

“A lot of the 100-day report, we view as movement in the right direction and we are pleased in what has been accomplished thus far,” Munger said.

After the HHS announcement, ACP said it “will work with the Administration and other stakeholders to implement policies that will lower the price and cost of prescription drugs and improve accessibility for patients.”

ACP did not offer public comments to the HHS this year, but it issued a position paper in 2016 that described ways it felt drug costs could be lowered. The College and AAFP are also among the medical societies that have also aligned themselves with the Campaign for Sustainable Rx Pricing, a nonpartisan coalition of organizations, including hospitals, insurers and nonprofit medical associations.

The American Gastroenterological Association also urged policymakers and stakeholders to improve drug affordability by maintaining “reasonable incentives” for developing and innovating therapies; decreasing out-of-pocket expenses for patients; increasing cost transparency; encouraging shared decision-making; and boosting competition.

An HHS spokesperson told Healio Family Medicine the agency is reviewing the comments received, and that there will likely be many actions regarding drug pricing in the weeks and months ahead.

Azar has previously cautioned that the full effect of the blueprint will not be felt immediately.

“[This plan] is nothing short of comprehensive reform of how drugs are priced,” he said at a hearing in June. “That doesn’t happen in a week or two; across the board change will take time.”

Stay tuned to Healio Family Medicine for continuing coverage. – by Janel Miller

 Disclosure: Healio Family Medicine was unable to determine relevant financial disclosures prior to publication.

President Donald J. Trump’s administration’s plan to lower drug prices — a 44-page document it calls the American Patients First Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs — has achieved results since its launch earlier this year, according to an HHS press release.

Lowering drug prices was one of the pledges then-candidate Trump made during his campaign.

The administration’s report on its efforts came shortly after the end of the public discussion period for a set of initiatives to lower drug prices from HHS. Several medical societies, including the American Academy of Family Physicians and AMA, submitted proposals and now wait to see if their suggestions were incorporated into the final rule. 

‘Unprecedented’ number of actions

“The President’s blueprint for lower drug prices is working, drug prices are coming down, and American patients are going to see the savings in their pocketbook,” HHS Secretary Alex Azar said in the release.

“At the time of the release of the blueprint, few observers believed that, within months, drug manufacturers would begin to change their annual ritual of significant price hikes. Yet that is what happened in the months following,” Dan Best, a senior advisor to Azar said in the release.

Pill Bottles
President Donald J. Trump’s administration’s plan to lower drug prices — a 44-page document it calls the American Patients First Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs — has achieved results since its launch earlier this year, according to an HHS press release.

Photo source: Shutterstock

 

Best and HHS noted these “unprecedented” actions since the blueprint was introduced on May 11:

  • 126 generic drugs approved in July;
  • 13 drug companies said they will not raise prices for the remainder of 2018;
  • 4 drug companies cancelled price increases;
  • 2 drug companies lowered drug prices;
  • 20 million seniors enrolled in Medicare Advantage have new negotiation tools;
  • A process that expedites development and review for products without market competition was implemented;
  • Proposals to drop payments for certain discounted drugs; to discourage both private-sector and pharmacist gag clauses; and to eliminate drug company Medicaid rebates moved forward;
  • Initiatives such as the Biosimilar Action Plan; promote competition and access to drugs; and address drug price spikes introduced;
  • Waiver to allow states to negotiate pricing contracts with drug makers granted;
  • Guidance to help insurers and drug companies “reach better deals” for patients provided;
  • Individual drug price increases displayed on CMS’s drug pricing dashboard; and
  • Comments on ways to use private-sector competitive acquisition for Medicare Part B drugs solicited.

Societies weigh in

PAGE BREAK

The AMA and American Academy of Family Physicians were among the more than 3,000 individuals or organizations that offered feedback on the blueprint earlier this summer during the public comment period.

James L. Madara , MD, AMA CEO and executive vice president, said the Association “strongly supports” mandating pharmaceutical supply chain transparency; speeding up and expanding regulatory action to increase pharmaceutical market competition and fight anti-competitive practices; assuring prescribers have correct point-of-care coverage and patient cost-sharing information as part of their workflow, particularly a patient’s electronic health record; and making sure federal programs and commercial practices billed as lowering prescription medication prices do so for patients directly.

But he also wrote AMA cannot support a proposals that would financially penalize physicians and pharmacists for high cost prescription medications; increase patient costs; or initiate insurer paperwork requirements that hinder timely patient access to affordable and medically necessary medications and treatments.

He discussed the toll high drug prices take on the medical community and their patients.

“Physicians experience and see first-hand the difficulty and burden high pharmaceutical costs have imposed on our patients, on physician practices, and the broader health care system,” Madara wrote.

“Patients are increasingly taking greater clinical risks when treatments are cost-prohibitive. When patients delay, forgo, or ration their medication, their health status may deteriorate. Patients who cannot afford their medication will eventually require medical interventions in more costly care settings, such as emergency departments, when their condition is at a more advanced stage of disease,” he added. “These price increases continue to occur among all segments of the market from innovator biologics to previously low-cost established generics. Physicians see every day that costs have become a major barrier to our patients getting the right medication at the right time.”

Madara’s letter also provided anecdotes from patients, medical students and practicing and retired medical professionals to illustrate each group’s respective concerns about the current drug pricing system.

John Meigs, Jr., MD, FAAFP , and AAFP board chair, said the administration should consider increasing access to generic drugs; address off-patent drugs; contemplate further expansion of the site-neutral payments for outpatient services in regards to physician-administered drugs; explore value-based drug pricing; provide Medicare negotiation authority; and engage in “prevention first” practices, measures that Meigs said would ensure the availability of what he called “effective, safe, and affordable” prescription medications.

PAGE BREAK

“Managing prescription drug prices for their patients is an important concern for family physicians,” he wrote in the AAFP response to the HHS proposal.

“Family physicians have a meaningful interest in the drug pricing debate, in part because of the complexity of care provided and the fact that the number and complexity of conditions, complaints, and diseases seen in family medicine is far greater than those seen by any other physician specialty. Ensuring access to medications is an integral part of a physician’s role as an advocate for their patients,” Meigs added.

Michael Munger, MD, president of the AAFP, told Healio Family Medicine, that many of the things that AAFP has been asking for regarding drug pricing are beginning to be addressed.

AAFP recognizes that the FDA has expedited the development and review of generic drugs that lack competition and has increased approvals of generic drugs, which is a positive, he said.

“AAFP has called for value-based pricing models that would link payment for drugs to more outcomes and cost effectiveness rather than pure volume of sales,” he said. So, the CMS waiver for states to negotiate value-based contracts with drug makers is a step in the right direction, according to Munger.

Allowing the Medicare advantage plans to have tools to negotiate prices for part B drugs is another move in the right direction, but the AAFP would still like to see the ability to negotiate for part D drugs, he said.

To further its progress, the administration should establish a site-neutral payment for physician-administered drugs, which would allow for good cost transparency and impact overall prices and restrict patent evergreen practices, according to Munger.

“A lot of the 100-day report, we view as movement in the right direction and we are pleased in what has been accomplished thus far,” Munger said.

After the HHS announcement, ACP said it “will work with the Administration and other stakeholders to implement policies that will lower the price and cost of prescription drugs and improve accessibility for patients.”

ACP did not offer public comments to the HHS this year, but it issued a position paper in 2016 that described ways it felt drug costs could be lowered. The College and AAFP are also among the medical societies that have also aligned themselves with the Campaign for Sustainable Rx Pricing, a nonpartisan coalition of organizations, including hospitals, insurers and nonprofit medical associations.

The American Gastroenterological Association also urged policymakers and stakeholders to improve drug affordability by maintaining “reasonable incentives” for developing and innovating therapies; decreasing out-of-pocket expenses for patients; increasing cost transparency; encouraging shared decision-making; and boosting competition.

An HHS spokesperson told Healio Family Medicine the agency is reviewing the comments received, and that there will likely be many actions regarding drug pricing in the weeks and months ahead.

Azar has previously cautioned that the full effect of the blueprint will not be felt immediately.

“[This plan] is nothing short of comprehensive reform of how drugs are priced,” he said at a hearing in June. “That doesn’t happen in a week or two; across the board change will take time.”

Stay tuned to Healio Family Medicine for continuing coverage. – by Janel Miller

 Disclosure: Healio Family Medicine was unable to determine relevant financial disclosures prior to publication.

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