Critical Moment for Prescription Drug Price Relief

AzPHA Partners with Protect Our Care on Radio Ad Urging Sinema to Support Price Reform

It’s no secret that prescription drug prices in the U.S. are far higher than in other countries and that the current system costs taxpayers, insurance plans and people far more than it should. A huge barrier has been language in the Medicare law that prevents HHS from directly negotiating drug prices under the Medicare Part D drug benefit program. 

Achieving prescription drug pricing reform (allowing Medicare to negotiate drug prices) has been out of reach for decades because the drug company lobby is so powerful that meaningful reform has been impossible.

Whether we achieve pricing relief will depend on what happens in the next month. The president’s Build Back Better plan includes a provision that would save the federal government and everyday consumers Billions of dollars per year in perpetuity by finally allowing Medicare to negotiate brand name drug prices with manufacturers.

The US House of Representatives has already passed a measure called “H.R. 3, the Lower Drug Costs Now Act of 2019” which would require HHS to negotiate the price of between 25-125 brand-name drugs without generic competitors. That negotiated price would be available Medicare, Medicaid and private payers. Importantly, HR 3 also provides some negotiating leverage to HHS.

For one thing, it would establish an upper limit for the negotiated price equal to 120% of the Average International Market price paid by Australia, Canada, France, Germany, Japan, and the UK.

It would impose financial penalties on drug companies that don’t comply with the negotiating process. Manufacturers that fail to negotiate would face an escalating excise tax on the previous year’s gross sales of the drug in question, starting at 65% and increasing by 10% every quarter to a maximum of 95%.

All indications are the Senator Kelly is on-board with allowing Medicare to negotiate with the pharmaceutical industry, but Senator Sinema hasn’t taken a position.

Because she appears to need a nudge, AzPHA partnered with Protect Our Care on a 60 second radio ad that urges listeners to call Senator Sinema’s office and urge to support the pricing reform parts of the Build Back Better plan.

Here’s a link to that 60 second radio call to action for voters to call Senator Sinema’s office and urge her to vote to allow Medicare to negotiate drug prices: NEW RADIO AD: AZ Health Care Advocate Will Humble Urges Senator Sinema to Let Medicare Negotiate Drug Prices — Protect Our Care

Federal OSHA to Take Over State OSHA (ADOSH) Oversight of Federal Labor Safety Due to Ducey Administration Nonperformance

On Tuesday, the Occupational Safety and Health Administration released a letter stating that they are taking steps to rescind its 1985 decision to allow the Industrial Commission of Arizona to oversee enforcement of federal safety rules via the Arizona State Plan.

Arizona has been considered a “home rule state” meaning that the Arizona Department of Occupational Safety and Health (ADOSH) can  enforce standards even if they varying from OSHA standards as long as certain criteria are met.

In their letter, OSHA alleges that ADOSH isn’t enforcing the Healthcare Emergency Temporary Standard interim final rule which includes masking requirements, and has not met the applicable standard to be permitted to enforce federal safety laws.

Their nonperformance of duties are almost certainly at the direction of Governor Ducey, who stops at nothing to ensure that Arizona does not implement evidence-based interventions to slow the spread of this virus.

Once OSHA rescinds the authority granted to ADOSH, OSHA will have back enforcement authority in Arizona over new COVID-19 and all other worker safety regulations.

CDC Establishes Vaccine Plan for 5-11 Year-Olds: It’s Time for Arizona to Do The Same

Once the CDC’s Advisory Committee on Immunization Practices meets on November 2 and 3rd about the Pfizer pediatric vaccine, HHS will begin releasing the pediatric vaccine to states. 

We’ve been urging the ADHS to develop a plan for deploying the pediatric vaccine for a few weeks now. They issued a blog post last week with a few details, but not a full plan. The CDC has published a detailed outline of their operational plan to quickly distribute and made conveniently and equitably available to families across the country.

HHS has purchased enough vaccine to vaccinate the U.S.’s 28 million kids that are between 5-11 years old. The pediatric vaccine is 1/3 the dose of the adult vaccine and will be coming in smaller boxes that will make it easier for physicians’ offices and other smaller, community-based providers to order what they need (they will come in 10-dose vials in cartons of 10 vials each). It will come with all the supplies that providers need to serve kids (including smaller needles).

The federal plan includes resources for states to stand up vaccination sites at: 1) pediatric offices and other primary care sites; 2) children’s hospitals; 3) pharmacies; and 4) school and community-based clinics (including through FEMA).

The federal government is doing their part, but the state health department will need to do their part to help the county health departments be successful. That means getting clear and detailed information to the county health departments and vaccinators about how they can order and deploy the vaccine.

The bottom line is that pediatric offices and other primary care sites, children’s hospitals, pharmacies, those interested in doing school and community-based clinics (including through FEMA) need clear guidance and a state operational plan. It will take a combination of all those sites operating in tandem to quickly be able to provide vaccination options for Arizona’s 634,000 kids between 5-11 years old.

Delta Wave Status Quo: Steady and High Community Transmission & Swamped Hospitals

View Dr. Gerald’s Full Weekly Report

Arizona continues to have high community transmission and a consistent influx of unvaccinated persons into general ward and ICU beds, pressing hospital teams and impacting care for both COVID & non-COVID patients.

Nineteen percent (1688) of Arizona’s 8754 general ward beds are occupied by mostly unvaccinated COVID-19 patients. Four hundred eighty-two (482, 27%) of Arizona’s 1774 ICU beds are occupied by COVID-19 patients, a 2% increase since last week.

While peak occupancy with this third wave never reached levels seen in the prior two, the base of the wave has the potential to be broader. For example, the summer 2020 and winter 2021 waves saw 57 and 98 days with combined ward and ICU occupancy >2000 patients, respectively.

The current #DeltaDucey wave has had 69 days with a combined occupancy >2000 patients. The persistent base of COVID-19 occupancy has important implications for hospitals as they attempt to meet high season demands from now until February.

View the Full Report

New AzPHA Report: COVID-19 Has Been the Leading Cause of Death During the Pandemic in Arizona

One of our AzPHA members, Allan N. Williams, MPH, PhD, recently retired from his role as a public health statistician at the Minnesota Department of Health and moved to AZ. He’s been helping us analyze key data in Arizona. His latest report was published this week and is entitled “COVID-19 As the Leading Cause of Death in Arizona During the Pandemic: An Evidence Review

Not surprisingly, our report found that COVID-19 has been the leading cause of death in Arizona during the pandemic. The fact that COVID deaths are currently comparable in prevalence to our two long-standing major killers – heart disease and cancer – is a sobering statistic and represents a deadly failure to control this pandemic.

Nationally, COVID-19 is the 3rd leading cause of death (behind cancer and heart disease). In states that had thoughtful governors and health directors who made evidence-based intervention decisions (e.g. statewide universal masking, enforcing mitigation measures in bars and nightclubs etc.) and who properly executed key operational priorities, COVID-19 is a distant 3rd (well behind heart disease and cancer).

To illustrate this we compare COVID-19 mortality in Arizaon to Colorado and Washington State (two Western states with similar populations). The difference between AZ, CO and WA is of course that Washington and Colorado have thoughtful governors that tried to mitigate the spread of COVID-19. Ours did not.

For example, in Figure 4 in our report shows that COVID 19 as a cause of death has been a DISTANT 3rd in CO and WA (well behind heart disease and cancer). The difference of course is that they have governors that care about whether people live or die.

Please take a look at this important report. It’s evidence that documents the gravity of the mistakes that Governor Ducey and Director Christ made during the pandemic. And remember, this ‘excess mortality’ represents lives that were unnecessarily lost. It represents people that would be with their families today but for the decisions made by Governor Ducey and Director Christ.

A huge thanks to Dr. Williams for his work bringing this important information to light.

West Nile Virus has Reached the Highest Levels Ever Recorded in Maricopa County

The West Nile Virus arrived for the first time that we know of in North American in 2003. There were cases East of the Mississippi that year, and the Eastern US did experience a significant outbreak that year. The next year was the Western US’ turn, and Arizona has several hundred cases of the West Nile virus that year. Most of us thought that 2004 would always be the worst year, but that is no longer true.

The number of West Nile virus cases has now exceed the number from 2004 in Arizona, most likely owing to the generous monsoon season that we had. The reason we thought we’d never have another year like 2004 is that the first year is almost always the worst for WNV. That’s because Arizona birds are the primary reservoir for the virus and in year one, all the birds are susceptible while in later years mostly just the new hatchlings are susceptible (mosquitoes spread the disease from bird to bird). Humans are more of a secondary reservoir.

Here are some factoids about WNV:

No symptoms in most people. Most people (8 out of 10) infected with West Nile virus do not develop any symptoms.

Febrile illness (fever) in some people. About 1 in 5 people who are infected develop a fever with other symptoms such as headache, body aches, joint pains, vomiting, diarrhea, or rash. Most people with febrile illness due to West Nile virus recover completely, but fatigue and weakness can last for weeks or months.

Serious symptoms in a few people. About 1 in 150 people who are infected develop a severe illness affecting the central nervous system such as encephalitis (inflammation of the brain) or meningitis (inflammation of the membranes that surround the brain and spinal cord).

  • Symptoms of severe illness include high fever, headache, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, vision loss, numbness and paralysis.
  • Severe illness can occur in people of any age; however, people over 60 years of age are at greater risk for severe illness if they are infected (1 in 50 people). People with certain medical conditions, such as cancer, diabetes, hypertension, kidney disease, and people who have received organ transplants, are also at greater risk.
  • Recovery from severe illness might take several weeks or months. Some effects to the central nervous system might be permanent.
  • About 1 out of 10 people who develop severe illness affecting the central nervous system die.

Diagnosis

  • See your healthcare provider if you develop the symptoms described above.
  • Your healthcare provider can order tests to look for West Nile virus infection.
  • To learn more about testing, visit our Healthcare Providers page.

Treatment

  • No vaccine or specific medicines are available for West Nile virus infection.
  • Over-the-counter pain relievers can be used to reduce fever and relieve some symptoms
  • In severe cases, patients often need to be hospitalized to receive supportive treatment, such as intravenous fluids, pain medication, and nursing care.
  • If you think you or a family member might have West Nile virus disease, talk with your health care provider.
  • To learn more about treatment, visit our Healthcare Providers page

For additional information and resources, please visit :

Arizona Has An On-line Portal to Get Your Immunization Record: Will It Work for You?

ADHS’ Vaccine Look Up Tool – AZ MyIR

With employer-based mandates kicking in and as folks approach the 6-8 month mark post their initial COVID-19 vaccine, it will be more and more important for folks to be able to access their vaccination records.

Fortunately, several years ago (back when I was with ADHS), we put together a tool so that parents could look up their kid’s vaccination records without going to the pediatrician to get a copy. It’s called MyIRMobile.  The idea was to provide a tool so that parents could save time and money by accessing your records at home for free. The tool is supposed to allow you to print out official immunization certificates to turn in to your child’s school or summer camp or whatever.

State law (ARS 36-135) requires vaccinators of children to input the data in to Arizona’s vaccine registry (called ASIIS), so the data in the system for kids should be fairly complete (for vaccines given in Arizona). Adult data is also in the registry and can be accessed by MyIR, but the data may not be as complete because while pharmacists are required to submit data into ASIIS, other providers are not.

However, all COVID-19 vaccine data should be in the system for both kids and adults because Executive Order 2020-57 requires all vaccinators to submit every dose of the COVID-19 vaccines.

I went into the system to check on my family’s records and was stymied. For a few days the system just gave me a message back that my ‘records will become available once my profiles are linked to the Arizona registry’. A few days later I got a request asking for my consent to link to ASIIS. I did that this morning. I’ll update this post later if I’m actually able to get my family’s vaccine records.

Technical assistance is also available, select this HELP link for General Information on MyIR Mobile, Frequently Asked Questions, User Guides or Chat. The Service Desk hours are 8 a.m. to 5 p.m. Monday through Friday.

October 26, 2021 Update: It took about a week, but my records did sync and it’s a reasonably good record of my immunization history. I also discovered that I forgot to get my Shingles booster… and the system is correct about that.

Hospitalizations Remain Stubbornly High with 25% of ICU Capacity Absorbed by Unvaccinated COVID Patients

#DeltaDucey Wave Continues to Take 200-300 Lives Per Week
View Dr. Joe Gerald’s Full Epidemiology & Hospital Occupancy Report

Arizona continues to experience high levels of community transmission with case rates modestly improving. Test positivity remains stubbornly high reminding us that test capacity, accessibility, and/or uptake is inadequate to meet public health needs. Plateauing among older, highly vaccinated groups serves as a warning that major behavioral shifts or waning immunity could result in future increases.

As of October 10th, new cases were being diagnosed at a rate of 203 cases per 100K residents per week. The rate was decreasing by 33 cases per 100K residents per week.

With waning vaccine efficacy and a potentially short duration of acquired immunity, the unvaccinated cannot “free ride” on high levels of community immunity. This means that persistently high levels of transmission, and more importantly hospitalizations, are possible for an extended time until the supply of unvaccinated, previously uninfected adults is exhausted.

Vaccination remains the most important public health priority to reduce transmission and severe illness; however, mask mandates, restrictions on indoor gatherings, and targeted business mitigations are still needed to reduce/control transmission in the short-run with the primary goal being to avoid overwhelming our critical care facilities and reducing pressure for new vaccine-escape variants.

Recent reports indicate that vaccine immunity to infection falls against Delta by 6 months. Because immunity against severe illness is long lasting, infections among the vaccinated will have less impact providing hope of an end-game where we can (mostly) live with SARS-CoV-2.

▪ https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02183-8/fulltext
▪ https://www.nejm.org/doi/full/10.1056/NEJMoa2114583
▪ https://www.nejm.org/doi/full/10.1056/NEJMoa2114114
▪ https://www.nejm.org/doi/full/10.1056/NEJMoa2110362
▪ https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00380-5/fulltext
▪ https://www.nejm.org/doi/full/10.1056/NEJMoa2113017

COVID-19 hospital occupancy is slowly improving. Nevertheless, occupancy continues to exceed 20% of all beds in the general ward and 25% of beds. Access to care will remain restricted in the face of staff shortages in inpatient and outpatient settings.

Weekly COVID-19 deaths continue to exceed 200 per week. The week ending September 5th has now recorded 300 deaths. Hopefully, this will be the first and only time during this third wave.

World Health Organization Recommends a New Malaria Vaccine for Highly Endemic Areas

Nevertheless, this vaccine isn’t a “game changer”

Malaria is an infectious disease caused by a parasite called parasite P. falciparum. People can get malaria when they’re bitten by a mosquito that is infected with the parasite. People typically experience symptoms 10–15 days after being bitten by an infected mosquito. Initial symptoms may be mild, including headache and fever, and it can be hard to tell whether they indicate malaria. However, these symptoms can quickly become life threatening without treatment in the first 24 hours.

Each year, there are an estimated 200 million cases of malaria worldwide, with about 90% in sub-Saharan Africa. Nearly half of all 2017 malaria cases worldwide occurred in five countries: Nigeria, Democratic Republic of the Congo, Mozambique, India and Uganda. Around 400,000 people die every year from malaria, most of them children under 5 years old (67%).  94% of all malaria deaths (and cases) occur in Africa.

Until now, control measures for malaria were mostly things like draining stagnant pools of water to eliminate mosquito breeding places, introducing mosquito larvae eating fish into waters and encouraging the use of mosquito nets at night. All difficult interventions to do at scale especially in rural areas with poor infrastructure.

This week saw a hopeful new development- with an announcement by the World Health Organization that they recommend administration of a new vaccine that is safe and reasonably effective at preventing the worst effects from malaria infections. 

This vaccine (called the RTS,S vaccine) was initially created in 1987 as part of a collaboration between GlaxoSmithKline (GSK) and the Walter Reed Army Institute of Research (WRAIR) that began in 1984. Oddly, pilot implementation in endemic countries until 2019 (I couldn’t find out why it took so long).

The Phase III clinical trial of the vaccine was picked up around 2001 with a public–private partnership with support from, you guessed it, the Bill and Melinda Gates Foundation. The vaccine’s effectiveness is modest, yet still provides significant public health benefit. The Phase 3 results demonstrated that among children who received 4 doses of vaccine, 1744 clinical malaria cases were prevented for every 1000 children vaccinated. Remember that this is a 4 dose series- challenging to do in rural high prevalence areas.

Modeling studies found that the vaccine would have marginal impact in areas where malaria prevalence is below 3%, and that the median incremental cost-effectiveness ratio is comparable to other current antimalarial interventions, including $25 USD per case averted and $87 USD per disability-adjusted life years averted, assuming $5 USD per dose of vaccine.

A description of the way the vaccine works is presented in this RTS,S/AS01 vaccine (Mosquirix™): an overview.

Editorial Note: This vaccine is an important development, representing the first vaccine against a parasite. The vaccine is moderately effective, but has a high return on investment public health wise in areas of high endemicity. The 4-dose series will be challenging to administer in rural areas where cases are highest. Finally, control measures like eliminating breeding places and protecting sleeping areas with nets and better access to treatment medications and hospitalization (when necessary) will continue to be critical in reducing morbidity and mortality from malaria- even in areas where the vaccine is deployed.

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