Opioid crisis a global problem which is accelerating in the US
Opioid abuse is today the most common cause of death from drug overdose. The problem is greatest in the US, where the number of deaths from overdoses increased by 21 percent in 2016.1) The opioid crisis in the US is epidemic in nature and costs society a great deal of resources. There is an excessive need for more and better treatment of those suffering from opioid dependence and the buprenorphine/ naloxone market is growing by just over 10 percent per year.2)
Opioid dependence a growing global concern
There are 25 million people in the world who are depend- ent on opioids.3) The problem exists in both developed countries and in less developed countries but is by far the greatest in the US, where a fifth of those dependent on opioids live.4) Heroin continues to be the predominantly abused opioid outside the US while Americans have developed dependence largely due to treatment with opioid prescription painkillers. Opioids, including heroin and synthetic illegal opioids, are the most harmful drugs. Worldwide at least 190,000 people die prematurely each year as a result of drugs and the majority of the deaths are caused by the use of opioids.5) The problem is acute in the US where just over 60,000 Americans died of an overdose in 2016.6) In 2017 the opioid crisis was classified as a Public Health Emergency, which means that resources should be allocated to avert or avoid public health crises.
In Europe, with an estimated 1.3 million high-risk opioid users,7) opioid dependence has not reached the epidemic proportions seen in the United States. However, there are several alarming signs that the problem is getting worse. The number of overdose-related deaths has increased for the third consecutive year 8) and misuse of synthetic illegal opioids is a growing health threat.9)
Misuse of opioids costs societies a great deal of resources
From an economic point of view opioid dependence is an extensive problem. In addition to loss of life and lower qual- ity of life, large costs are associated with lower productivity and a lack of resources, and there are also increased healthcare and legal systems costs. In the US costs related to opioid dependence are enormous and considerably higher than previously calculated. The Council of Economic Advisors, which is an advisory committee to the American President, came out in 2017 with the report entitled “The Under-estimated Costs of the Opioid Crisis”. This report shows that the cost to society of the opioid crisis amounted to USD 504 billion in 2015, or 2.8 percent of GDP. This amount is six times higher than the most recent calculation, where loss of life as a result of overdoses has not been taken into account.
American market characterized by strong growth
A sharp increase in prescription painkillers over a little more than two decades is the primary reason that today there are an estimated 10 million high-risk users of opioids in the US. Half of these have developed dependence and just over 16 percent are undergoing treatment. One of the most common and effective treatment alternatives is mainten- ance treatments based on the substances buprenorphine/ naloxone. The market for buprenorphine/naloxone products has grown substantially in recent years. Annual growth is just over 10 percent and the value of the market is estimated to be more than USD 2.6 billion.10) Considerable political and media focus has increased knowledge and awareness of opioid dependence and its risks, which has led to more people seeking help. The Affordable Care Act, ACA, has resulted in more people gaining access to subsidized care. In spite of the work done, it is still only a small percent who receive treatment. The development of the market is primarily impacted by continued improved access to treatment, which is made possible by a good range of cost-effective treatment and drugs but also by the fact that more doctors and nurses have gained approval to treat and that they are beginning to treat more patients.
Market consists of three payer segments, where Public is the largest
The market consists of three payer segments. Commercial, which comprises private insurance companies, Cash & Vouchers, where patients themselves finance their care, and Public, where care is financed by public sector payers such as Managed Medicaid, FFS Medicaid and Medicare Part D. Public differs from the other segments in that it is to a great extent stringently controlled by payers with regard to what drugs may be prescribed and which physician you as a patient can choose. Pharmacy Benefit Managers (PBM) play an important role, as they are responsible for assessing on behalf of the insurance companies and employers which drugs are to be covered by insurance.
The public segment is the largest and consists of 46 percent of the market for buprenorphine/naloxone products, while the corresponding figure for the Commercial and Cash segments is 39 percent and 15 percent, respectively.
Publicly financed care growing fastest and characterized by price pressure
The Public segment has grown the fastest in recent years, driven by the fact that more and more people have gained access to publicly financed healthcare through the ACA and due to the fact that employers have become more restrictive in offering private healthcare insurance.
The market is generally characterized by price pressure. This is above all true in the Public segment, which is stringently controlled and which has seen discount levels increase. In comparison with other pharmaceutical markets, generics have not had a significant price pressure effect.
However, generics are favored by the fact that many insurance companies in the Public segment automatically give generics priority and thus indirectly put pressure on companies with new products to lower the price if insurance companies are to deviate from this principle. Since the launch of Zubsolv® the list price of generics has been on a par with or a little higher than that of the drugs sold under patent-protected brand names, but recently there have been campaigns from individual generic companies which have reduced the price to patients in the Cash seg- ment to somewhat lower levels.
The leading player has a strong position and a market share of just under 70 percent.11) However, development of the market share displayed a negative trend during 2017. There are multiple generic company players and their combined market share amounts to 25 percent.12) Orexo’s share of the market is just over 5 percent.13) There is also a smaller company in the market, selling under its own brand. Their share of the market is approximately 0.5 percent.14)
Painkiller abuse can open the door to heroin
The lack of treatment availability has given rise to the growth of the illegal market. Prescription painkiller drugs are frequently bought on the illegal market and the price is governed by the quantity of active substance per unit in the drug, which means that drugs with a higher bioavailability fetch a lower “street” price. Increased focus on the control of the prescription of drugs containing opioids, in combination with the fact that the price of heroin and synthetic illegal opioids is most often lower, has resulted in opioid dependent patients running an increased risk of beginning to use more heroin 15) and/or illegal synthetic opioids. Two thirds of today’s heroin abusers have previously abused pre- scription opioid painkillers.16) Heroin gives a faster high, but the strength of each dose varies greatly and may be mixed with synthetic illegal opioids, which is one of the main reasons for the explosive increase in the number of overdoses and deaths.
2. IMS Data
3. World Drug Report
4. UNODC World Drug Report 2014
5. World Drug Report 2017
7. European Drug Report 2017
8. European Drug Report 2017
9. European Drug Report 2017
10.-14. IMS Data
15. https://www.drugabuse.gov/publications/research-reports/heroin/how- heroin-linked-to-prescription-drug-abuse
16. Grace Chang, MD MPH Professor of Psychiatry, Harvard Medical School, The Opioid Crisis in America, 11 October 2016