#NHOTC17: Day 2

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This week we publish our second and final blog update on our 28th European OTC INSIGHT conference, which took place in Munich earlier this month and was centred on the theme of Making the Most of New Technology. Below is a quick round-up of proceedings on Day 2.

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Ed Rowland opens Day 2 proceedings

Ed Rowland opened the conference with an update on key drivers and dynamics in the US OTC strategic landscape. Akhil Chandra of Reckitt Benckiser led us into our final networking hour with a discussion on what makes an iconic brand in a world of biosimilar products. Chandra based his talk around the “iconicity” of Nurofen, insisting that when it comes to brands we should challenge the tendency to default, and instead create, identify and nurture iconic / symbolic elements.

Following an hour of networking with OTC peers, our delegates returned for our final session with Jesus Carrasco, Head of Healthcare at Société Générale, who discussed consolidation and the increasing attractiveness of the consumer healthcare industry from a corporate and investor perspective.

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Thornsten Umland from Bayer gave the final presentation on strategic growth and how to build OTC businesses and brands via well executed acquisition and true product innovation.

And finally, a personal message from Nicholas: “Thank you all for making a brilliantly successful conference, the array of speakers and topics covered have certainly left us all with food for thought on the OTC landscape in a world of digital!

As an official announcement, now the conference has ended, we hope to see you next year in… BARCELONA for our 29th European OTC conference #NHOTC18. Auf Wiedersehen or should I say… Adios!”

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Nielsen-CHPA Survey on OTC Allergy Trends

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Coughing, sneezing, a runny nose and itchy eyes are just some of the symptoms of seasonal or chronic allergies, one of the most common ailments impacting the lives of Americans today, according to a new white paper on Rx-to-OTC allergy switches, produced by Nielsen and the US OTC industry association, Consumer Health Products Association (CHPA).

In 2015, 27.8% of Americans suffered from allergies, which translates to approximately 69 million adults, and 89 million people overall. Since 2009, a number of ingredients, including antihistamines and intranasal steroids that were only available Rx, have now switched to OTC, giving consumers more options to treat their allergies.

While there is abundant data to show that allergy OTC sales have grown significantly owing to the increasing number of brands available, there haven’t been many studies conducted to understand how these Rx-to- OTC switches have benefitted allergy sufferers.

Nielsen’s latest report assesses the consumer benefits of allergy Rx-OTC switches to help gain an understanding of allergy-suffering consumers and how having access to more oral and nasal OTC medications has contributed to their financial and personal wellbeing.

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The survey is made up of data based around allergy patient visits, the number of prescriptions written by month, the costs for each, and corresponding insurance-related costs. Nielsen also provided data on allergy sufferer penetration, their buying behaviour, and how each consumer treats their ailment. 
A survey was also fielded to 2,000 adult allergy sufferers to better understand their treatment routine and overall satisfaction with their medication options.

The report found that more and more Americans are suffering from allergies. Over the time period analysed, the number of individuals who stated that they suffer from allergies has increased. There are approximately 9.7mn more allergy sufferers today than there were
 in 2010.

There has also been a clear shift to OTCs. 
The number of allergy sufferers taking OTCs has increased, while 
at the same time the number of sufferers taking prescription medications has declined. Just as importantly, the report also found that allergy sufferers who take OTCs are highly satisfied with the medication options available to them.

The report is available to download here.

American Health Care Act unveiled

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The Trump administration’s long-awaited replacement plan for the Affordable Care Act has now been released. The American Health Care Act (AHCA) was developed in conjunction with the White House and Senate Republicans.

Despite the replacement plan being released, two big questions still remain unanswered. How many people will the plan cover and how much will it cost?

It is likely that the plan will cover fewer people than the Affordable Care Act currently does, but exactly how many has not been specified. The Congressional Budget office has not yet scored the legislation, so the current costs are unknown.

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Early assessment of the replacement act seems to indicate that:

  • Some of Obamacare’s signature features have been entirely eradicated, such as the tax on people who don’t purchase healthcare. Other protections, including the ban on discriminating in regard to people with pre-existing conditions and the provision that allows young adults to stay on their parents’ plan until age 26, would survive
  • The plan maintains the Medicaid expansion – the Affordable Care Act has expanded Medicaid to cover millions of low-income Americans
  • According to critics, the replacement plan benefits people who are healthy and high-income and disadvantages those who are sick and lower income. The replacement plan would make several changes to what health insurers can charge enrolees who purchase insurance on the individual market, as well as changing what benefits their plans must cover
  • The bill looks a lot more like Obamacare than previous drafts. A curious thing has happened to the Republican replacement plan as it has evolved through multiple drafts; it has begun to look more and more like Obamacare itself.

Nicholas Hall will be bringing his regional conference series to North America in 2017, with our 1st North American OTC Conference, being held in the OTC hub of New Jersey on 27-28 June 2017. You can join us for a gloves-off discussion on how recent political changes in the US will affect future healthcare. Early Bird rates are available until the end of March only! Please contact lianne.hill@NicholasHall.com now to find out more or register your interest.

Trump To Roll Back E-cig Rules?

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As vaping has escalated in popularity over the past year, tobacco companies are focusing on new smoking products, which are potentially less harmful. With Trump now in his full role of presidency, the industry sees an opening for rolling back rules on these products.

In November, Trump’s surprise election victory, and his pledges to reduce federal regulations on business, led tobacco lobby groups to create a new plan of action. The immediate objective is to delay the implementation of new regulations on the current generation of e-cigarettes and other vaping devices. These devices produce a vapour from liquid nicotine rather than burning tobacco.

Longer-term, they are setting their sights on repealing the 2016 law that treats these devices like cigarettes. Lobbyists have described a wary optimism as they approach lawmakers with their plans for products that they say can help traditional smokers quit and avoid the well-known health threats caused by tobacco.

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With US sales of conventional cigarettes decreasing, Big Tobacco has made a major gamble in the past few years, flying the flag for the e-cigarette industry. Last week, British American Tobacco Plc announced a US$49bn deal to take over competitor Reynolds American, uniting two of the largest e-cigarette players in the United States and United Kingdom and becoming a huge rival to Philip Morris International and US partner Altria Group.

“Suddenly things that were not conceivable became something we thought we could do,” said Cynthia Cabrera, former president and executive director for the Smoke-Free Alternatives Trade Association (SFATA).

While the potential health risks and benefits of e-cigarettes are still being studied and debated, with regulators in different countries interpreting the evidence in different ways, some industry voices are saying that a change in US regulations could hurt the smaller companies there and cripple development and innovation in the country’s e-cigarette industry.

IBIS AND HRA AIM TO SWITCH THE PILL TO OTC

Ibis Reproductive Health and French-based HRA Pharma are working together to provide the research needed to submit an application to the US FDA to switch a progestin-only daily use oral contraceptive (OC) to OTC. For over a decade Ibis has worked with a broad coalition of healthcare providers, advocates and researchers in the Oral Contraceptives OTC Working group to build the evidence and make the case for the benefits of moving a birth control pill OTC.

Ibis highlights that too many people in the US face barriers to accessing the birth control they want and that a safe and effective OC would help people overcome some of those barriers. The coalition is committed to conducting the research and advocacy to ensure any OTC method is covered by health insurance and available to everyone who needs it.

HRA Pharma has already seen success in Rx-to-OTC switch in the EU, with its application to the European Medicines Agency to reclassify its emergency hormonal contraceptive ellaOne (ulipristal acetate 30mg) approved by the European Commission in early 2015 via the centralised procedure.

In an exclusive comment to the OTC.NewDirections team, Ibis Reproductive Health’s VP for Development & Public Affairs Britt Wahlin said: We are thrilled to be working with HRA Pharma in this effort that has been driven by demand from consumers and medical professionals. It’s past time we have an FDA approved OTC birth control pill, which would make it easier for women and men all across the country to determine how and when to have children and give them greater control over their lives and reproductive health. Currently, under the Affordable Care Act, most private insurance plans have to cover all types of FDA-approved birth control for women without any cost-sharing. This includes OTC methods used by women – though only if a healthcare provider prescribes them. We hope that women will be able to use their insurance for an OTC birth control pill without having to get a prescription.

A new law in Maryland is a promising direction. It will require coverage of OTC contraceptive medications without a prescription starting in 2018 and we hope more states will follow suit. Efforts are underway to dismantle the ACA and we have yet to learn what concrete plans there are to replace it. The birth control coverage provision is a crucial piece of the ACA. Millions of women have benefited from greater access to birth control and contraception is not one size fits all; insurance coverage of the full range of methods is critical so that women truly have a choice.

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Also, HRA Pharma’s US Portfolio Strategy Director Stéphanie Pradet told the OTC.NewDirections team: HRA Pharma is proud to partner with Ibis Reproductive Health and the OC OTC Working Group to bring to the US market a safe and effective over-the-counter contraceptive. At HRA, we are proud of our pioneering work to expand access to contraception for millions of women. We share the OC OTC Working Group’s commitment to increasing safe and effective options for preventing pregnancy and improving the reproductive health of women in the US.

Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts. The science is clear, and US experts including The American College of Obstetricians & Gynecologists, the American Medical Association and the American Academy of Family Physicians agree that oral contraceptives are appropriate as an over-the-counter option. We look forward to working together to build a future where each woman can get the safe and highly effective birth control method she prefers.

Vit D shows metabolic syndrome benefits

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It is well known to some that a diet high in fat can trigger a metabolic syndrome; a group of symptoms that pose as risk factors for diabetes and heart disease. Scientists have now discovered that vitamin D deficiency is necessary for this syndrome in mice, with primary disturbances in gut bacteria.

If these findings can be validated in humans, sunbathing and vitamin D supplements may be affordable approaches to improve or even prevent metabolic syndrome.

“Based on this study, we believe that keeping vitamin D levels high, either through sun exposure, diet or supplementation, is beneficial for prevention and treatment of metabolic syndrome,” says Professor Stephen Pandol, at Cedars-Sinai Medical Center, USA, who collaborated with Yuan-Ping Han’s research group at Sichuan University, China in the study.

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Metabolic syndrome affects nearly one-fourth of the world’s adult population. Characteristic symptoms include obesity around the waistline and at least two of the following: high blood sugar levels, high blood pressure or high cholesterol; sufferers also typically have excess fat in their liver.

Vitamin D deficiency decreases the production of defensins, which are antimicrobial molecules essential to maintain healthy gut flora. As expected, an oral supply of a synthetic defensin recovers gut bacteria balance, decreases blood sugar levels and improves fatty liver.

In summary, a high fat diet alone is not enough to cause metabolic syndrome but ultimately it is needed in combination with vitamin D deficiency.

FDA takes steps to improve hearing aid accessibility

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The U.S. Food and Drug Administration (FDA) have announced important steps to better support consumer access to hearing aids. The FDA will consider creating a category of OTC hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The agency also announced important steps to better support consumer access to hearing aids. In a guidance document, the agency explains that it does not intend to enforce the requirement that people aged 18+ years receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. Under the new guidance, the FDA will continue to enforce the medical evaluation required for people under 18 years of age.

The agency also requires that consumers are provided with information and instructions about hearing aids before any purchase from a licensed hearing aid dispenser. This guidance is effective immediately.

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FDA Commissioner Robert Califf, M.D commented “Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,”Califf continued “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life.