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Guidelines Updates in Diabetes and Cardiovascular Disease
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Guidelines Updates in Diabetes and Cardiovascular Disease

Mary Caffrey
A statement on hypoglycemia, an consensus document from cardiologists on diabetes and CVD, and guidelines on treating cholesterol.
after adjusting the statin dose. This step should be repeated every 3 to 12 months, as often as necessary.

The guidelines also include a recommendation for a quality-and-value discussion of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, which were approved to great fanfare in 2015 after results from clinical trials showed they could reduce LDL cholesterol levels by up to 60%. But list prices of more than $14,000 a year caused formulary

managers to restrict access to only the most at-risk patients. In recent months, manufacturers have cut prices, after Sanofi worked out an agreement with Express Scripts (SP617).

Under the deal, Express Scripts will reduce prices and speed access for those who meet FDA-approved criteria of clinical ASCVD or heterozygous familial hypercholesterolemia and inability to achieve safe levels of LDL cholesterol even while taking maximally tolerated statins. In return, Sanofi’s alirocumab (Praluent) will receive exclusive

formulary access instead of Amgen’s evolocumab (Repatha). In October, Amgen reduced prices for evolocumab as well.

“There have been concerns over the cost of PCSK9 inhibitors, and some insurance companies have been slow to cover them, so it’s important to note that the economic value of these new medications may be substantial only for a very specific group of people for whom other treatments haven’t worked,” Ivor Benjamin, MD, FAHA, president of the AHA,

said in a statement. “The association is bringing together stakeholders to discuss financial barriers to the care of heart disease and stroke. We have been heartened that drugmakers have recently agreed to reduce the prices of PSCK9 inhibitors and are making arrangements with payers to ease the financial burden for patients who could benefit from

the additional medication options.”4 

References

1. Gundy SM, Stone NJ, Bailey Al, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on the clinical practice guidelines [published online November 10, 2018]. Circulation. doi:

10.1161/CIR.0000000000000625.

2. American Heart Association News. New guidelines for cholesterol should be on everyone’s radar beginning early in life. American Heart Association website. heart.org/en/news/2018/11/10/new-guidelinescholesterol-should-be-on-everyones-radar-beginning-early-in-life. Published November 10, 2018. Accessed November 15, 2018.

3. Goff DC, Lloyd-Jones DM, Bennett G, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013

ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [erratum in J Am Coll Cardiol 2014;63(25 pt B):3026]. J Am Coll Cardiol. 2014;63(25 pt B):2935-2959. doi: 10.1016/j.jacc.2013.

4. Updated cholesterol guidelines offer more personalized risk assessment, additional treatment options for people at the highest risk [news release]. Chicago, IL: American Heart Association; November 10, 2018. newsroom.heart.org/news/updated-cholesterol-guidelines-offer-more-personalized-risk-assessment-additional-treatment-options-for-people-at-the-highest-risk. Accessed November 15, 2018.


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