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Colorado bill would exempt ‘orphan’ drugs from affordability review


Three years after its creation, the state board with the power to limit the cost of some prescription medication in Colorado could be restricted on the types of drugs it can review.

Senate Bill 24-60 would exempt drugs used to treat rare diseases that affect fewer than 200,000 people in the country, known as orphan drugs. That means the Prescription Drug Affordability Review Board would not be able to declare those drugs unaffordable or set an upper payment limit on them.

The bill cleared its first committee on Thursday on a bipartisan 3-2 vote.

Sponsors said the bill would make sure that people with rare diseases continue to have access to treatment, as orphan drugs are often for diseases with no other medication option. Upper payment limits or the threat of them, they argue, could push manufacturers to stop selling those drugs in the state because of the possibility of financial loss.

That was the worry the approximately 400 Coloradans who use Trikafta, a drug that treats cystic fibrosis, had when in December the PDAB weighed whether it was unaffordable.

“The PDAB eventually did not set an upper payment limit on the cystic fibrosis drug. Great. But what’s next?” bill sponsor Sen. Barbara Kirkmeyer, a Weld County Republican, said.

“It sets a chilling effect on all of these people with rare diseases,” she said. “I’m not here for Big Pharma. I know they make money on stuff. That’s not the issue — it’s what happens if you were to put an upper payment limit on the drug, or just even present the possibility.”

The PDAB eventually did not set an upper payment limit on the cystic fibrosis drug. Great. But what’s next?

– Bill sponsor Sen. Barbara Kirkmeyer

On Friday, the PDAB voted to move forward with setting a price cap on Enbrel, which treats arthritis and has one orphan designation for the six conditions it is approved to treat. It was the first time in the country a state authority had taken such a step.

Kirkmeyer is running SB-60 with Democratic Sen. Joann Ginal of Fort Collins.

Supporters said the bill would not impact the board’s ability to review the many prescription drugs that do not have a designated orphan status and have a much higher patient load. In 2021, orphan drug sales accounted for about 15% of prescription drug sales worldwide.

Opponents, however, argue that the bill would critically weaken the PDAB and its ability to curb high drug costs.

“If orphan drug prices that could treat (my husband) remain out of control, our reality will never be about the relief of these medications, it will instead be about paying into that $1.6 million lifetime tab, straining health care resources for the state while we try to cobble together health management tactics,” said Tamika Matthews, a Consumer Advisory Board member with the Colorado Consumer Health Initiative whose husband lives with sickle cell disease.

Opponents also argued that some drugs with an orphan designation actually treat fairly common conditions, and some are not quite “orphan,” since other drugs can treat the rare condition. Humira, for example, is an orphan drug that treats arthritis and psoriasis but has many competitors.

“It’s shocking to me that a medication that helps treat arthritis, psoriasis, Crohn’s disease and ulcerative colitis has a designation for conditions that affect under 200,000 people,” said Austin Blumenfeld, the executive director of the left-leaning Centennial State Prosperity. “Senate Bill 60 would take away the ability for Colorado’s PDAB to review 67% of the approximately 600 drugs eligible for review.”

CCHI estimated that about 400 of the 600 drugs that the PDAB identified as possible for review have at least one orphan designation.

Democratic Sen. James Coleman joined Republican Sens. Mark Baisley and Larry Liston to advance the bill. Coleman said he thinks the bill deserves broader conversation, but he will likely oppose it on the floor.

Democrats control substantial majorities in both chambers of the Legislature.



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