The Rheumatoid Arthritis Scenario in India

Introduction

Rheumatoid Arthritis (RA) is a systemic disease—an autoimmune disorder in which the body's defense system attacks the joints through the thin layer of cells called the synovium that lines and lubricates the joints. The most visible symptoms of RA are swollen joints and crippling stiffness, particularly of the hands and feet. It can cause fatigue, fever, loss of appetite, and also impedes mobility and quality of life.

RA is a common autoimmune disease, which affects about 20 million persons worldwide. The disease commonly develops between the ages of 25 and 50 and given its progressive nature, patients often live for 30 years or more with the disease.

Incidence and Prevalence

In India there are about 11 million people with RA, of whom about 75.0 percent are women. While India would require about 70,000 specialists to treat them all, it has only between 100 and 150 rheumatologists at present, putting pressure on them in terms of patient load and the time they are able to spend with each patient.

Prevalence of RA was about 0.75 percent in 2004, and has risen to 1.0 percent in 2007. The number of diagnosed patients is likely to increase due to the increasing awareness of the disease. As for treatment, DMARDs are the treatment of choice and for moderate to severe cases, biologics may be added. Unlike other countries, Remicade was the first biologic to be available in the market, although Enbrel captured a larger market share after it was introduced.

Diagnostic Tests

The diagnosis of RA is based on clinical examination of symptoms, patient history, as well as blood tests. There is no absolute test that can confirm or exclude RA. Some of the common tests include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), and X-ray.

Rheumatologists use a suite of parameters in confirming an RA diagnosis and monitoring disease progression.

The vital parameters in confirming diagnosis and determining disease progression are:

• Number of swollen joints

• Presence of morning stiffness

• Number of tender joints

• Functional status

Key Treaters and Patient Flow

GPs treat patients for joint-ache with steroids and NSAIDs, and refer RA patients to orthopedic surgeons and rheumatologists for further treatment. Orthopedic surgeons, also, are often the first point of contact. They would diagnose and prescribe DMARDs. Patients with severe RA or those who require treatment beyond DMARDs are directed to a rheumatologist. Rheumatologists are the key treaters of RA.

The main treatment goals include:

• Reduction in pain, swelling and thus the inflammation

• Reducing joint deformity

• Improving quality of life

Treatment Options

Most of the patients are initially treated with only drugs. Patients on drugs and physiotherapy would be those with concomitant diseases. Patients also practice yoga, exercises that are designed to cure the inflicted joints by slow movements and gentle pressure in conjunction with deep breathing. There are a very small proportion of patients who are not on any treatment because of their refusal to be treated.

Most commonly used drugs for the treatment and management of Rheumatoid arthritis are:

• Steroids / NSAIDs (Non Steroidal Anti Inflammatory Drugs) / Cox-2 inhibitors
• DMARDS (Disease Modifying Anti-Rheumatic Drugs) in monotherapy or combination therapy
• Biologics

Though Biologics are the most effective treatment options available till date for the RA treatment, high cost of therapy acts as a barrier for its frequent usage. Available biologics in India are Enbrel (Etanercept), Remicade (Infliximab), Orencia (Abatacept), Rituxan/Mabthera (Rituximab) and Actemra (Tocilizumab).

Treatment Filter

-- Total RA patients: 100%

-- Patients diagnosed: 3.37%

-- RA patients available for treatment: 2.5%

-- RA patients eligible to be treated with biologics: Less than 1%

-- Patients actually treated with biologics: !!!

Government and Non-government Initiatives

Mission Arthritis India (MAI) is a voluntary support group for patients of arthritis and rheumatism, established in 2000. It was formed by a group of people who are suffering from chronic arthritis and wish to help the community fight these ailments. The main goal of MAI is to provide proper and scientific information and guidance about all aspects of arthritis and related problems. MAI publishes quarterly newsletters containing health-related articles and organizes public awareness meetings during the week 12 - 20 October every year, in which the annual health magazine is inaugurated. Various health talks by well-known doctors from the field of orthopedics, rheumatology and other specialties are also arranged in this program.

Bone and Joint Decade India : National Action Networks (BJD – India: NAN), under the umbrella of the WHO-endorsed Bone and Joint Decade 2000 – 2010, is engaged in disseminating general awareness about rheumatic musculoskeletal disorders both for the medical community and the Indian public. It has established corporate partnerships with some Indian pharmaceutical companies that are interested in building awareness. The organization has also set up multiple studies to collect population-based prevalence data.

Market Challenges

• High cost of treatment with biologics
• Lack of awareness among the patients
• Low Rheumatologists to patient ratio
• Low reimbursement scenario
• Patients drop out because of low compliance results
• Around 30% of patients are non-compliant with treatment with DMARDs either due to side effects, Patients’ attitude that the treatment is not working or inclination to use alternative therapies.

• More than 90% of patients do not continue treatment with biologics till one year either due to high cost of biologics or side effects. In many cases where patient pay out of pocket for biologics, it is given to relieve the patient from painful symptoms and then treatment is continued with DMARDs.

Future Outlook

Though there are biologics available for treating RA, specialists in India will continue to use DMARDs as their first line therapy, because of high cost of treatment and fear of side effects associated with long term usage with biologics. However, improving reimbursement scenario, increasing disposal income, increasing awareness among the Indian population about RA and continuous effort by the companies for increasing usage of biologics are few of the factors which will drive the growth of RA market.

Author Information:
- Bibhuti Bhusan Kar, Program Manager - Pharmaceuticals and Biotechnology, Frost & Sullivan, India.

- Source: Pharma Bio World, April 2010

-Link: http://www.pharmabioworld.com/archives.html

The perishables business injects profits for carriers

With growing globalisation the perishables business has taken off, but the highly sensitive cargo — be it flowers, fruit, meat or pharmaceuticals — requires greater investment in specialised ULDs and expertise. Manfred Singh reports.

It is likely that not many of us have seen the new 10x10 cm handling label that has been developed for the transportation of temperaturecontrolled, time-sensitive goods. Affixed by the shipper, the labels are intended to signal to handlers the need to maintain such packages at between 15°C and 25°Cambient temperature.

Though the use of the label has not yet become mandatory, airlines and freight forwarders are becoming increasingly aware that transporting such goods is treading a thin line and constitutes a whole gamut of risk management. If there is one cargo that is solely dependent on ULDs, it is the perishable trade and obviously the fast-moving — read pharma — variety. As a perishable expert puts it, the difference between a perishable-loaded ULD arriving on time, or arriving late could mean life or death for the products within. Getting it right means a business segment with huge growth potential. Ram Menen, Emirates’ divisional senior VP, Cargo, points out that perishables handling has grown “by leaps and bounds in the last five years”.

Pharma is big business 

In short, perishables are important for the air cargo business. Forecasts by IMS Health Incorporated, a provider of market intelligence to the pharmaceutical and healthcare industries covering more than 100 countries, pointed out that the global market value of pharma products could exceed US$975 billion by 2013. The importance, therefore, of the ‘perishable’ goods industry to air cargo was more than evident at the recent 20th Annual IATA Cargo Network Services at Miami in the US. A session titled, ‘Time & Temperature Logistics for Healthcare Products’ outlined how the product has grown and the kind of work that the IATA’s Time & Temperature Task Force (TTTF), a body in its Live Animals and Perishables Board (LAPB), was undertaking.

According to a study by Frost & Sullivan’s programme manager, Pharmaceuticals and Biotechnology, South Asia & Middle East, Bibhuti Bhusan Kar, the global pharmaceutical logistics market recorded revenues of about $90.3 billion in 2008. That included services such as freight, warehousing, and express logistics. Freight forwarders estimate that logistics comprises 45-55 per cent of the costs in the pharmaceutical value chain.

From the air cargo point of view, a single perishable pharmaceutical unit could cost anywhere between $5,000 to $7,000 and a full ULD would contain more than $30 million of goods. A close look at how critical the business is, according to LifeConEx – the only industry-specific Lead Logistics Provider (LLP) of end-to-end temperature controlled transportation solutions for the life sciences industry worldwide – indicates that 20 per cent of the world’s best selling pharmaceuticals are temperature sensitive; $130 billion of the total pharmaceutical market is represented by temperature sensitive products; and nearly 100 per cent of all vaccines and 68 per cent of all products sold by biotech companies have to be stored and transported between +2ºC and +8ºC.

The transportation of healthcare and life-saving goods is governed by IATA’s Time and Temperature Task Force (TTTF). Mandated to develop and maintain standards for the procedures, documentation, cargo handling, packaging and acceptance of goods from the health care sector in order to facilitate, improve or maintain the logistics, the TTTF acts as the liaison with all stakeholders from the health care industry or their intermediaries. TTTF members include pharmaceutical industry companies, forwarders, airlines and temperature-controlled container manufacturers.

A growing focus by carriers

On their part, air carriers, forwarders and container manufacturers are keen to develop a wide variety of new products and services that would facilitate transportation. Said Emirates’ Menen: “Our perishable business has been quite steady even during the recessionary period and post recession is on the growth path. We carried good loads of fruit and vegetables and pharma throughout 2009.”

Emirates, for example, offers special cool chain solutions that are designed for the movement of temperature-sensitive goods. The airline also offers speciallydesigned temperature-controlled air cargo containers that maintain stable interior temperatures throughout the journey. These feature active temperature control systems that range from -20C to +20C. In addition, Emirates SkyCargo joined hands with a US research institute to develop a low-cost, light weight, breathable and reusable protective ‘White Cover’ designed to shield temperaturesensitive shipments from heat during airport-to-airport transportation.

Similarly, American Airlines has teamed up with Envirotainer to develop an active temperature-controlled air transportation solutions including the RKN e1 unit, which is the latest. The RKN e1 has been designed in collaboration with ThermoKing for requirements of the life sciences industry capable of maintaining temperatures in the +2 to 8 °C range, as well as in room temperature.

FedEx Custom Critical also uses the Envirotainer technologies. Continental Airlines also has an agreement with CSafe, a maker of active cooling units that recently received the licenses from the FAA for its technology. CSafe’s compressor-based units have both cooling and heating capabilities and can sustain consistent interior temperatures in ambient extremes from –30 to +50 degrees Celsius.

On the other side of the spectrum are other perishable items like flowers, fruits fish and meat products and vegetables. All require the same “cool’ treatment and are big business. Carriers like Emirates go through an intricate process that boosts the life of perishable commodities by ‘preserving the cool chain’ throughout the journey. Even so, most carriers maintained that respective governments could help by facilitating the necessary infrastructure at airports in the form of temperature-controlled facilities required to clear and store such cargo. To top it all, custom authorities could also assist in facilitating movement of such ULDs into and out of the bonded facility so that cool chain integrity could be maintained during the entire supply chain.

- Source: PayloadAsia.com, June 2010

- Link: http://www.payloadasia.com/article-5332-theperishablesbusinessinjectsprofitsforcarriers-PayloadAsia.html#