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Biopharma-Payers-seek-National-Guidelines-For-Prescribing-Potential-COVID-19

The Pharmaceutical Research and Manufacturers of America, America’s Health Insurance Plans and other players in the drug supply chain are urging the Trump Administration and Congress to develop national guidelines for prescribing potential treatments for COVID-19.

In a March 26 letter to Vice President Mike Pence and leaders in the House and Senate, the organizations expressed concern that “as drugs are identified as potential treatments for COVID-19, the demand may outstrip the supply.”

As a nation, it continues, “it is imperative we balance the need to find drugs that may be helpful to treat COVID-19 while still making them reasonably available to patients who currently rely on them for established treatment.”

That challenge has arisen with hydroxycholorquinone, which is approved for rheumatoid arthritis, lupus and malaria, and chloroquinone, which is also approved for malaria.  They are now in short supply in the US after a spike in off label use driven by some evidence of a benefit against COVID-19 and an enthusiastic endorsement from President Trump. (Also see "Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy" - Pink Sheet, 23 Mar, 2020.)

Hydroxychloroquine is currently under investigation in a number of clinical trials for COVID-19 prophylaxis and treatment and several are planned or will be enrolling soon in the US. The FDA also just granted it an emergency use authorization to add to the national stockpile.

To ensure a consistent approach to providing access to such drugs, “we recommend clinical guidance for health care providers be issued to ensure that patients who have been on therapies for FDA-approved indications prior to the spread of COVID-19 still have appropriate access, as well as those with COVID-19,” the letter says.

Furthermore, “it is important to prioritize access to drugs for patients in FDA clinical trials, which assist in evidence generation for COVID-19 treatments and vaccines for the entire population,” the groups urge.

“Without national clinical guidelines on this issue, health care providers and patients will be subject to differing rules and timelines by state and local regulators, resulting in confusion, perceptions of unfairness, and practical complexities, including point-of-sale related issues,” the letter warns. The lack of guidelines will also impede “the nation’s ability to help ensure individuals are not stockpiling medications that are needed by other or their immediate health care needs.”
Opposition To ‘Buy America’ Executive Order

The letter also urges the Administration against proceeding with a “Buy America” executive order, which has been under consideration by the White House.

The order is intended to address dependency on countries like China for the manufacture of medicines, medical supplies, and medical equipment. It is also supposed to attract investment in domestic manufacturing by calling for the Veterans Administration, the Health and Human Services Department and the Defense Department to buy medicines and medical supplies and equipment from domestic sources. (Also see "Trump Counts On China To Deliver In The Day Of The Coronavirus" - Pink Sheet, 17 Mar, 2020.)

“It is critical that the US government not take steps that many have an unintended impact on the supply of pharmaceuticals in the United States,” the letter maintains.“All of our industries are concerned that a reported ‘Buy America’ executive order under consideration by the White House could have an immediate and detrimental impact on the ability of American who rely on federally funded health programs to access their medicines.”

In addition to PhRMA and AHIP, the letter was signed by the Pharmaceutical Care Management Association, Association for Accessible Medicines, Academy of Managed Care Pharmacy, Blue Cross Blue Shield Association and National Association of Chain Drug Stores.The Pharmaceutical Research and Manufacturers of America, America’s Health Insurance Plans and other players in the drug supply chain are urging the Trump Administration and Congress to develop national guidelines for prescribing potential treatments for COVID-19.

In a March 26 letter to Vice President Mike Pence and leaders in the House and Senate, the organizations expressed concern that “as drugs are identified as potential treatments for COVID-19, the demand may outstrip the supply.”

As a nation, it continues, “it is imperative we balance the need to find drugs that may be helpful to treat COVID-19 while still making them reasonably available to patients who currently rely on them for established treatment.”

That challenge has arisen with hydroxycholorquinone, which is approved for rheumatoid arthritis, lupus and malaria, and chloroquinone, which is also approved for malaria.  They are now in short supply in the US after a spike in off label use driven by some evidence of a benefit against COVID-19 and an enthusiastic endorsement from President Trump. (Also see "Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy" - Pink Sheet, 23 Mar, 2020.)

Hydroxychloroquine is currently under investigation in a number of clinical trials for COVID-19 prophylaxis and treatment and several are planned or will be enrolling soon in the US. The FDA also just granted it an emergency use authorization to add to the national stockpile.

To ensure a consistent approach to providing access to such drugs, “we recommend clinical guidance for health care providers be issued to ensure that patients who have been on therapies for FDA-approved indications prior to the spread of COVID-19 still have appropriate access, as well as those with COVID-19,” the letter says.

Furthermore, “it is important to prioritize access to drugs for patients in FDA clinical trials, which assist in evidence generation for COVID-19 treatments and vaccines for the entire population,” the groups urge.

“Without national clinical guidelines on this issue, health care providers and patients will be subject to differing rules and timelines by state and local regulators, resulting in confusion, perceptions of unfairness, and practical complexities, including point-of-sale related issues,” the letter warns. The lack of guidelines will also impede “the nation’s ability to help ensure individuals are not stockpiling medications that are needed by other or their immediate health care needs.”
Opposition To ‘Buy America’ Executive Order

The letter also urges the Administration against proceeding with a “Buy America” executive order, which has been under consideration by the White House.

The order is intended to address dependency on countries like China for the manufacture of medicines, medical supplies, and medical equipment. It is also supposed to attract investment in domestic manufacturing by calling for the Veterans Administration, the Health and Human Services Department and the Defense Department to buy medicines and medical supplies and equipment from domestic sources. (Also see "Trump Counts On China To Deliver In The Day Of The Coronavirus" - Pink Sheet, 17 Mar, 2020.)

“It is critical that the US government not take steps that many have an unintended impact on the supply of pharmaceuticals in the United States,” the letter maintains.“All of our industries are concerned that a reported ‘Buy America’ executive order under consideration by the White House could have an immediate and detrimental impact on the ability of American who rely on federally funded health programs to access their medicines.”

In addition to PhRMA and AHIP, the letter was signed by the Pharmaceutical Care Management Association, Association for Accessible Medicines, Academy of Managed Care Pharmacy, Blue Cross Blue Shield Association and National Association of Chain Drug Stores.

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