OTC hearing aids: Awaiting US Senate vote

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Cheaply priced reading glasses have long been available to buy without prescription in supermarkets and pharmacies. While there is an available OTC product for some living with farsightedness, there is still yet to be an approved inexpensive over-the-counter equivalent for those living with mild-to-moderate hearing loss.

Medicare and most private insurance plans in the US do not cover prescription hearing aids, which cost around $2,400 for one device. Owing to this, it is thought that many people with hearing loss go without hearing aids because they cannot afford the devices.

This could be changing soon, as the House of Representatives has passed legislation that would create a new class of hearing aids that could be sold OTC.

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“We get inquiries every day from people who cannot afford hearing aids,” said Nancy Macklin, a spokeswoman for the Hearing Loss Association of America. According to a 2016 study from the National Academies of Sciences, Engineering & Medicine, just 14% of those with hearing loss use a hearing aid.

While there are several types of less expensive non-prescription personal sound amplification devices on the market, the devices are not regulated by any government entity for safety or quality standards and are used to aid people with normal hearing but wish to amplify sound.

Recent advances in technology have made the concept of less-expensive, OTC hearing aids very possible. The potential switch is part of the FDA Reauthorization Act of 2017, which the House passed Wednesday with a voice vote. The bill received widespread bipartisan support, but the Senate has yet to announce a timeline for holding a vote on the bill.

The arrival of OTC hearing aids can’t come soon enough for an ageing population that is continually growing. As Baby Boomers age and Generation X hits middle age, the number of people with mild to moderate hearing loss is increasing rapidly.

NHC North America Conference: Day 2

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Here’s the second and final blog review of our recent regional North American OTC Conference, which took place last week at The Westin Governor Morris hotel in Morristown, New Jersey.

Our first speaker on Day 2, Bernie Simone, Head of Rx-to-OTC Switches NA, Sanofi, discussed the growth engine for consumer healthcare and improved consumer self-care relating to Rx-to-OTC Switch, and highlighted how 43% of OTC industry sales are associated with a Switch, with almost half of proposed Switches failing. Bernie also explained the concern that Switch will no longer be possible if the medical community does not approve, and so it is imperative that we as an industry think of new initiatives to involve communities in the earlier stages of the Switch process in order to identify viable and novel Switch candidates.

Following Bernie on stage was Chuck Jolly from Baker Donelsen, who reviewed legal risk amelioration strategies that can be adopted by marketers to safeguard their practices, leading us into our first networking hour of the day.

Vidhu Dev, VP, Rx-to-OTC Switch & R&D, GSK, then gave us an informative outlook on Switch overseas and the likely future challenges and successes, before focusing back on the local US market – for example, the US OTC allergy market has continued Switch activity, is highly competitive and dominant. Vidhu also identified possible categories for OTC switch candidates, such as antifungals, anti-diabetics and cough & cold, and the evolving role of the pharmacist will be integral in making this possible.

Our panel then took to the stage, debating the establishment of collaborative relationships with payer, retail and CPG entities to put the consumer first and deliver superior outcomes.

Shannon Huneke of UHC, Colleen Lindholz of Kroger & Chris Jobes of J&J came together to discuss their collaboration in the healthcare ecosystem. Together they discussed their marriage of information on consumer insight and their segmentation of this, and how this equips them in the battle against industry challenges, and transforms the behavioural science behind consumer healthcare. The panel also mapped the patient’s journey through their condition, with each journey presenting an opportunity to translate individual patient requirements. They concluded by asserting that we can’t get where we want to be in healthcare without partnerships – and if we can create a healthier population, we all win!

Our unplugged panel session continued as Christina Speck, Head of Brand Partnerships & Sponsorships, Aetna, and Brian Doherty, Executive VP, Managing Director, Ogilvy CommonHealth, joined forces to discuss partnerships, technology and engaging healthcare consumers in the real world. Together Christina and Brian discussed consumers living in a digital age, with Christina mainly focusing on Aetna’s partnership with Apple products and apps. Christina highlighted how healthcare and well-care are not exactly fun (but they should be!), which is where the combination of technology creates a vision for this, connecting clinical and well-care, and demystifying healthcare communications.

Our panel discussions certainly gave some food for thought in time for lunch, with many delegates taking the time to discuss and debate the key learnings with industry peers. Returning from lunch, we saw Walmart executives Alex Hurd, Senior Director of Health & Wellness Transformation, and Jamie Grace, Senior Director & Merchandise Manager, explore the role of retail in providing access to high quality care at lower costs.

John Delfs from The Foundation for Health Smart Consumers shared with the audience the need to empower consumers through motivation and collaboration with HCPs, and was followed by Randy Vogenberg from the National Institute of Collaborative Healthcare, who gave us an insight into access trends for OTCs, delving into innovation, incubation and implementation.

Mary Alice Lawless, from our conference partners, EverythingHEALTH, then took to the stage to identify and analyse new strategies for unlocking the next generation of Rx-to-OTC Switch, before an esteemed panel of moderators debated the next steps in consumer healthcare transformation. Panellists included Joseph McGovern of EverythingHEALTH, Andrea Leondard-Segal, former FDA Director of the Division of Nonprescription Clinical Evaluation, Helmut Albrecht, President of H2A-Associates, and Dennis Tze, Biograph Inc. Together they asked whether we should provide case studies for the Switch industry, questioning how we can enhance changes in Switch through branding and digital.

Overall our first North American conference was a real success, with a fantastic turn out, excellent insights, a riveting display of speakers and plenty of industry knowledge. We certainly hope to see you next year and thank you all for joining us in this first time North American conference experience!

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.

Q3 Results Reveal USA Slowdown

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The Q3 2016 results are now available on Nicholas Hall’s DB6 database, and the trend information will soon be updated on the OTC DASHBOARD website. In this week’s blog, we take a closer look at the latest growth trends for the Top 20 OTC markets in the world.

Overall, the global OTC market performed steadily in Q3 2016 with a 4.3% rise, the same growth rate as we saw in Q2 2016. However, this performance can be seen as mediocre compared to the full-year 2015 period, when OTC sales were up by 5.5%.

The global No.1 market, USA, showed signs of deceleration in Q3, with sales up by only 2.2%. This is largely owing to the slowing down of sales for major switches, such as Flonase allergy remedy and Pfizer’s Nexium 24HR antacid. That said, the USA should enjoy an upturn in the new year with switches such as GSK’s Flonase Sensimist (allergy remedy) and Galderma’s Differin Gel (acne remedy) in the pipeline. Compared to other categories, Lifestyle OTCs in the USA showed continued dynamism in Q3 2016, with sales up by a steady 5.0%; this was owing in part to double-digit growth for obesity treatments (+43.4%).

China’s growth also continued to lose steam in Q3 2016, where sales were up by 6.0%. China’s OTC market continues to grow year-on-year, but in recent years growth has gradually slowed; this is considered to be owing to a weaker economy, new regulations and also the crackdown on MNCs and domestic companies. Weaker growth overall in Q3 came despite continued growth for analgesics, which were up by 8.4%, making it the most dynamic OTC category in China, thanks to high levels of innovation and advertising in this area.

In Q3, growth also weakened in Japan and Europe as a result of low levels of Rx-to-OTC switch activity and weak cough, cold & allergy growth in early 2016. Italy was an exception to sluggish growth in Europe, where sales of OTCs were up by 3.5%; this was thanks to strong growth for Lifestyle OTCs (+11.1%), with a particularly dynamic performance from emergency hormonal contraceptives, sales of which rose by 226%.

Latin America remains the strongest performing region, with growth up by 15%. This is thanks to significant growth from Venezuela, up by 39% in Q3, owing to high levels of inflation. Despite a tough economic climate in Brazil, the OTC market remains robust with sales up by 9.5%, as a result of increased awareness of health and wellbeing.

Elsewhere in Q3 2016, India’s growth accelerated with sales up by 9.5%, owing to a strong performance from gastrointestinals (+10.3%). Turkey also performed well with growth up by 6.8%, thanks to VMS sales and a strong upturn for Lifestyle OTCs.

US acne OTC market ready to pop

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It’s amazing that the OTC treatment of acne has been limited to benzoyl peroxide and salicylic acid treatments for more than three decades, but now US teens and adults suffering from the condition have new options in the form of a medical device and the pending launch of an Rx-to-OTC switch topical gel.

J&J has launched Neutrogena Light Therapy Acne Mask, said to harness the power of clinically proven technology to clear acne and allow skin to heal itself. The mask emits blue light to kill acne-causing bacteria, while its red light goes deeper to reduce inflammation. Use is simple, with people putting the mask on after cleansing their faces and pushing the button and letting it work for 10 minutes.

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The US$40 mask includes 30 treatments, and subsequent purchases of the Light Mask Activator for US$17 means the mask can be charged for another 30 treatments. Although there are many light devices for acne treatment available on e-commerce sites like Amazon, the cachet of the trusted leading OTC acne brand, Neutrogena, on the label, and the far lower price point compared to other devices makes this product a game-changer.

Meanwhile, Galderma (Nestlé) is getting ready to launch Differin Gel (adapalene), the first retinoid acne treatment to be available as an OTC when the FDA approved its switch from Rx-only status last summer. The topical drug will dramatically change the complexion of retail shelves with a new ingredient for a skin condition that can have a major quality of life impact on millions of consumers. The Differin website promises that the new OTC will be on retail shelves soon.

This month, OTC INSIGHT North America will cover the acne remedies market in more detail as part 2 of its skin care report. To learn more about INA, click below:

Nicholas Hall’s OTC INSIGHT regional periodicals

Esomeprazole, Ibuprofen OTC Changes Take Effect In Canada

In February this year, Health Canada announced its intention to make two changes to the Prescription Drug List (PDL). Specifically, it was proposed that the PDL be amended to allow an OTC version of esomeprazole for heartburn and to make technical changes that would permit modified-release ibuprofen products available for self-care.

While this announcement was not a surprise as the six-month period for comment elapsed on 5th August, the delay in making the change effective (18th August) was more likely owing to administrative matters than anything therapeutic in nature. The two changes to the federal list are as follows:

  • Esomeprazole or its salts except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg
  • Ibuprofen or its salts except:
    1. An oral dosage form that provides 400mg or less per dosage unit; or
    2. A modified-release oral dosage form that provides 600mg or less per dosage unit

While the Federal decision had no further restrictions attached, the provincial scheduling of these products do take on some further limitations as decided by the National Association of Pharmacy Regulatory Authorities (NAPRA).

Now that the federal switches are finalised, the interim decision made by NAPRA becomes effective. Specifically, the provincial decision on these two items were:

  • Ibuprofen or its salts, when sold in a modified-release oral dosage form that provides 600mg or less per dosage unit would be placed into Schedule III (sold only where a pharmacist is present)
  • Esomeprazole or its salts, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg, in package sizes of no more than esomeprazole 280mg would be assigned to Schedule II (available only from a pharmacist directly)
  • Esomeprazole or its salts, EXCEPT when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg in package sizes of no more than esomeprazole 280mg will not be switched provincially (it will remain in Schedule I – Rx only)

The ibuprofen decision was notable since the regular dosage form is available as an unscheduled item (available through any outlet when sold in package sizes of up to 18,000mg) while the modified release product is restricted. The esomeprazole decision matched the decision made for omeprazole in 2014.

Nicholas Hall’s Latin American conference: Day 2

On day 2 of Nicholas Hall’s 2nd Annual Latin American OTC Conference we saw our latest new venture, the OTC Training Academy, get to work with our speakers and delegates.

Our Brazilian correspondent, Sergio Santos, gave an informative introduction to attendees, who then took part in an intense brainstorming session and shared their industry knowledge to create a marketing scheme for a fictitious OTC product.

As well as being an enjoyable session, the project overall delivered some great ideas fuelled by OTC marketing expertise at its best.

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The conference went back into full swing shortly after the workshop seeing another array of speakers. Key speakers of the day were:

  • Joe McGovern from everythingHEALTH who gave a presentation on switch updates relating to the OTC market in Latin America
  • Followed by Jose Antonio Valdez, who spoke about PGT, a healthcare company merger between P&G and Teva
  • Stephen Schulte of Nature’s Way spoke about entering international VMS markets. We were also offered a tester of the company’s latest product, a sweet-like vitamin, which is available in numerous flavours
  • Rui da Silva, founder of Expatbiotics, was the last speaker of the conference giving us a vision of the future, discussing Skin Care in 2020 and its role in the Latin consumer trade and industry.

Nicholas Hall closed the conference, mentioning the focus of digital within our OTC market and how it was incorporated into many of the presentations. Overall, the conference gave an excellent insight into the Latin American OTC market and its current position and future outlook.